MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-12-23 for ALLEVYN LIFE NON-BRDR 10X20CM CTN10 66801751 manufactured by Smith & Nephew Medical Ltd..
[172450288]
It was reported that the product was used on a highly exudated leg ulcer. The dressing soaked some of the exudates but left a lot on the wound surface despite they choose a larger size of the dressing. There were no delays and no patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2019-00941 |
| MDR Report Key | 9508963 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-10 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2019-12-23 |
| 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 |
| 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 LIFE NON-BRDR 10X20CM CTN10 |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-12-23 |
| Catalog Number | 66801751 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-12-23 |