FDA Adverse Event
Death
Summary report: N
AQUACEL EXTRA 5X5CM
MDR report key: 5097412
·
Received September 23, 2015
Report
- Report Number
- 1000317571-2015-30161
- Event Type
- Death
- Date Received
- September 23, 2015
- Report Date
- February 27, 2014
- Manufacturer
- CONVATEC LIMITED
- Product Code
- NAC
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 "PATIENT DIED IN HOSPITAL. REASON NOT KNOWN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629150 | AQUACEL EXTRA 5X5CM | DRESSING,WOUND,HYDROPHILIC | NAC | CONVATEC LIMITED | 420671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Death |