FDA Adverse Event
Malfunction
Summary report: N
AQUACEL AG SCD DRS 9X25CM
MDR report key: 5104272
·
Received September 25, 2015
Report
- Report Number
- 1000317571-2015-30028
- Event Type
- Malfunction
- Date Received
- September 25, 2015
- Report Date
- February 27, 2014
- Manufacturer
- CONVATEC LIMITED
- Product Code
- FRO
- PMA / PMN Number
- K091034
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem · 1
IT WAS REPORTED THAT "1 DRESSING WAS VERY ADHERENT TO THE PATIENTS SKIN AND DIFFICULT TO REMOVE. HAD BEEN IN PLACE FOR 5 DAYS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 634391 | AQUACEL AG SCD DRS 9X25CM | DRESSING, WOUND, DRUG | FRO | CONVATEC LIMITED | 412011 | 1D02457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |