FDA Adverse Event
Injury
Summary report: N
ALLEVYN LIFE S 10.3X10.3 CTN10
MDR report key: 5152829
·
Received October 15, 2015
Report
- Report Number
- 8043484-2015-00280
- Event Type
- Injury
- Date Received
- October 15, 2015
- Date of Event
- July 9, 2015
- Report Date
- September 25, 2015
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITH & NEPHEW, MEDICAL LTD. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, MEDICAL LTD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCTS DOES NOT ABSORB WELL AND REQUIRES CHANGING WITHIN THE 7 DAY WEAR TIME. IT WAS ALSO NOTICED THAT THE WOUNDS ARE MACERATED AND TAKING LONGER THAN THEY USUALLY TAKE TO HEAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684734 | ALLEVYN LIFE S 10.3X10.3 CTN10 | DRESSING, WOUND, OCCLUSIVE | NAD | SMITH & NEPHEW MEDICAL LTD. | 66801067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |