MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-04-03 for REMOVE WIPES manufactured by Smith & Nephew Medical Ltd..
[71463927]
Patient Sequence No: 1, Text Type: N, H10
[71463928]
It was reported that a patient suffered from bumps/blisters on the face. The user? S relatives have excluded the plasters and surgical tape as the cause and now believe that the remove wipes caused the reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2017-00100 |
| MDR Report Key | 6452624 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-03-08 |
| Date Added to Maude | 2017-04-03 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SPAN PACKAGING SERVICES |
| Manufacturer Street | LLC. 4611 DAIRY ROAD SUITE A, GREENVILLE |
| Manufacturer City | SC 29607 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29607 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMOVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2017-04-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-03 |