MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT manufactured by Smith & Nephew Medical Ltd..
| Report Number | 8043484-2019-00653 |
| MDR Report Key | 9087448 |
| Date Received | 2019-09-19 |
| Date of Report | 2019-09-19 |
| Date of Event | 2019-07-08 |
| Date Mfgr Received | 2019-08-23 |
| Date Added to Maude | 2019-09-19 |
| 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 | DRA SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD HULL |
| Manufacturer Country | UK |
| Manufacturer Phone | 4407940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-09-19 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-09-19 |