DUODERM PASTE AND GELS
Received Feb 12, 2026
Report 1000317571-2026-00019 · MDR key 24329738
Device
Generic name
Dressing, Wound, Hydrogel Without Drug And/or Biologic
Manufacturer
Convatec LtdModel number
187987Product problems
- Gel Leak
- Delivered as Unsterile Product
- Device Damaged Prior to Use
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE DISTRIBUTOR AND END USER REGARDING THE LEAKAGE IN THE GEL PACKAGE EVEN THOUGH THE PACKAGE HAD NOT BEEN OPENED. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Additional Manufacturer Narrative
E1: COMPLAINANT STREET ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE:1000317571.