DUODERM
Received Jul 31, 2026
Report 9618003-2026-01213 · MDR key 50098175
Device
Generic name
Dressing,wound,occlusive
Manufacturer
Convatec Dominican Republic IncModel number
187957Lot number
4G04854
Product problems
- Nonstandard Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The distributor reported that the dressing was unable to absorb the exudate. The product was being used, however duration of use was unknown. A video and photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
E1: (b)(6). Patient Name or Identifier:(b)(6).Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. FDA Registration NumberReporting Site: 1049092Manufacturing Site: 9618003.