GYNECARE GYNEMESH

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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. 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: PLEASE CONFIRM THE OUTCOME. ACCORDING TO THE INFORMATION ABOVE, THE PATIENT DID NOT RECOVER FROM THEIR UTI FROM 23 DEC 2009. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WERE ANY CONCURRENT DEVICES IMPLANTED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE (LAPAROSCOPIC, OPEN)? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED FOR THE URINARY TRACT INFECTIONS INCLUDING MEDICATION NAME AND RESULTS. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? FACILITY NAME? PRODUCT CODE AND LOT NUMBER?

Description of Event or Problem

IT WAS REPORTED VIA CLINICAL TRIAL THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A RECURRENT UTI AFTER SURGERY. LOG LINE: 1 ADVERSE EVENT TERM: RECURRENT UTI AFTER SURGERY START DATE: (B)(6) 2009. DATE OF SURGERY: (B)(6) 2008. SEVERITY : MILD. RELATIONSHIP TO STUDY DEVICE : UNLIKELY. RELATIONSHIP TO PRIMARY STUDY PROCEDURE : UNLIKELY. INTERVENTION/TREATMENT: NONE: NO. DRUG THERAPY: YES. OUTCOME VALUE: NOT RECOVERED/NOT RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED.