FDA Adverse Event
Malfunction
Summary report: N
L3W0900 - AQUACEL AG
MDR report key: 13247029
·
Received January 13, 2022
Report
- Report Number
- 1000317571-2022-00003
- Event Type
- Malfunction
- Date Received
- January 13, 2022
- Report Date
- December 14, 2021
- Manufacturer
- CONVATEC LTD
- Product Code
- FRO
- PMA / PMN Number
- K013814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMMON DEVICE NAME: DRESSING, WOUND, DRUG. (B)(6). (B)(4). 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. (B)(4).
Additional Manufacturer Narrative · 0
THIS EMDR IS BEING SUBMITTED TO CORRECT D1: BRAND NAME , D2: COMMON DEVICE NAME & PRODUCT CODE, D4: MODEL# & G4: PMA /510(K)#.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS FOREIGN BODY (FLY) ON THE DRESSING. THE PRODUCT WAS NOT USED ON PATIENT. THE PICTURES OF THE CONCERN WERE PROVIDED WELL.
Description of Event or Problem · 0
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Description of Event or Problem · 0
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784999 | L3W0900 - AQUACEL AG | DRESSING, WOUND, DRUG | FRO | CONVATEC LTD | 403711 | 1B04132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |