DERMABOND UNKNOWN PRODUCT
Received Feb 13, 2025 · Event occurred Dec 18, 2024
Report 2210968-2025-01652 · MDR key 21378310
Device
Generic name
Class I Device - Exempt
Manufacturer
Ethicon Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Wound Dehiscence
- Abscess
- Unspecified Infection
- Itching Sensation
- Pain
- Urticaria
- Impaired Healing
- Skin Inflammation/ Irritation
- Wound Dehiscence
- Abscess
- Unspecified Infection
- Itching Sensation
- Pain
- Urticaria
- Impaired Healing
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. SHOULD FURTHER DETAILS BE PROVIDED, THE FILE WILL BE UPDATED ACCORDINGLY. NO PRODUCT IS AVAILABLE FOR RETURN. 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.
Description of Event or Problem
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND TOPICAL SKIN ADHESIVE WAS USED. AT POST-OP DAY 08, SEVERE URTICARIA AROUND THE WOUNDS WITH INFECTION, INTENSE PRURITUS, PAIN, WOUND DEHISCENCE AND VESICULAR DERMATITIS OF THE FLANK STARTING FROM ONE OF THE SCARS. CURRENT STATE OF PATIENT: DELAYED HEALING, INFECTION, ABSCESS, PAIN, PRURITUS. AS NO CONTACT INFORMATION HAS BEEN PROVIDED.