N
Patient 1
MAUDE MDR 7982340
- MDR report key
- 7982340
- Report number
- 8043484-2018-00337
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-09-20
- Date received
- 2018-10-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- DR. SARAH FREESTONE
- Address
- 101 HESSLE ROAD HULL, HU3 2 UK
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | REMOVE WIPES BOX OF 50 01 | SOLVENT, ADHESIVE TAPE | SMITH & NEPHEW MEDICAL LTD. | KOX | 403100 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-18 | 0 | 1. O; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT PATIENT SUFFERED FROM BURNS DURING USE OF THE PRODUCT.
N
Patient 1
WE HAVE NOW CONCLUDED OUR INVESTIGATION INTO THIS PRODUCT COMPLAINT FOR A REMOVE WIPES WHICH CAUSED BURNING. VISUAL INSPECTION OF THE PRODUCT COULD NOT BE COMPLETED SINCE THE PRODUCT TUBE WAS NOT RETURNED. ALSO WITHOUT A LOT NUMBER, A REVIEW OF THE PACKAGING BATCH RECORD COULD NOT BE COMPLETED. ALL BATCHES ARE TESTED FOR COMPLIANCE WITH PRODUCT SPECIFICATIONS PRIOR TO RELEASE. COMPLAINTS OF A SIMILAR NATURE WILL BE CLOSELY MONITORED FOR ANY ADVERSE TRENDS AND FURTHER ACTION CONSIDERED. SMITH AND NEPHEW ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS AND WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.