MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-26 for ALLEVYN GENTLE BORDER LITE 15X15CM 66800840 manufactured by Smith & Nephew Medical Ltd..
[174182360]
It was reported that the nurse reported to a pharmacist from a city pharmacy that she placed a bandage on a patient's wound. When she removed the bandage, almost all the silicone remained on the wound bed. The problem was solved taking out the pieces with tweezers and the nurse no longer used the dressings with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2019-00957 |
| MDR Report Key | 9522282 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-26 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2019-12-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEVYN GENTLE BORDER LITE 15X15CM |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-12-26 |
| Catalog Number | 66800840 |
| Lot Number | 201914 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-26 |