ETHICON

Description of Event or Problem

It was reported that a patient underwent a Lap Ablation of Endometriosis procedure on an unknown date and absorbable hemostat powder was used. A GYN Surgeon reported that she has had two recent cases of infection and abscess when using absorbable hemostat powder. Both cases patients presented with signs of infection (ie. fever, in one case took back to the OR, drained and confirmed bacteria); she noted this was not post-op imaging of a mass suspected abscess. She also noted that she irrigated out excess Powder before closing. She said both patients procedures were excision of extensive endometriosis, and also were more complicated cases with higher risk potential for both patients. However, she added that until 1 year ago, she used Arista with zero infections and abscess from the product for several years, and two infections in recent months gave her concern about absorbable hemostat Powder. Excision of endometriosis, lysis of adhesions, possibly removal of tubes or ovary, uncertain. Additional information was requested

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.To date the device has not been returned. If the device or further details are received at a later date a Supplemental Medwatch will be sent.Additional information was requested, and the following was obtained: ¿ Did the patient experience an Adverse Event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> Yes,¿ Did the patient require revision surgery or hardware removal? --> Yes,¿ Was Device Explanted? --> FALSE,¿ Did patient require revision surgery? --> FALSE,¿ Patient Status/ Outcome / consequences --> Yes,¿ Patient Consequence Description/Was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> infection,¿ Was other medical intervention (e.g. X-rays, additional procedures, prescriptions, OTC, revision) required: --> Yes,¿ If yes, describe --> return to hospital, took back to OR, drained; treated infection medically,¿ Is the patient part of a Clinical Study --> Unknown.Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a Supplemental Medwatch will be sent.1. Please provide the following patient demographic information, if available: age, gender, weight, BMI at the time of index procedure?2. What was the date of index surgical procedure?3. What were the diagnosis and indication for the index surgical procedure? 4. Please provide any relevant patient history: patient pre-existing medical conditions (i.e. Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.5. Was there any intraoperative concurrent use of other products?6. What is the lot number?7. What was the intended use of the SURGICEL? Was it used to address active bleeding or used prophylactically?8. Where was the SURGICEL used (on what tissue)?9. Please describe the patient manifestations of the reported infection (location, severity, appearance).10. Please provide the onset date/time of infection from the initial surgical procedure.11. Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure?12. Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?13. Were cultures and sensitivities performed? If so, please provide the results.14. How much and what type of drainage is present in this wound? (If applicable)15. Please describe any medical intervention performed including medication name and results. 16. Were any pre-op cleansing procedures changed recently? If yes, please describe17. What is physician¿s opinion as to the cause of this event?18. Was there an alleged deficiency of the SURGICEL that contributed to the patient¿s post-operative events?19. What is the patient¿s current status?20. What is the users experience w/ Surgicel Powder and other hemostatic agents?This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Ethicon, or its employees that the report constitutes an admission that the product, Ethicon, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.