FDA Adverse Event
Injury
Summary report: N
ALLEVYN LIFE SACRUM
MDR report key: 6120048
·
Received November 22, 2016
Report
- Report Number
- 8043484-2016-00165
- Event Type
- Injury
- Date Received
- November 22, 2016
- Date of Event
- September 14, 2016
- Report Date
- November 10, 2016
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED UPON REMOVAL OF DRESSING IT WAS NOTED SILICONE ADHESIVE RESIDUE ON PERI WOUND SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770463 | ALLEVYN LIFE SACRUM | DRESSING,WOUND,OCCLUSIVE | NAD | SMITH & NEPHEW MEDICAL LTD. | 66801306 | 1534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |