MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-11 for UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT manufactured by Smith & Nephew Medical Ltd..
[94421148]
Patient Sequence No: 1, Text Type: N, H10
[94421149]
It was reported an adverse skin reaction with skin peeled before putting over a picc line dressing.
Patient Sequence No: 1, Text Type: D, B5
[109128568]
Device was not evaluated due to sample was not returned for investigation. Please see investigation summary attached. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00307 |
| MDR Report Key | 7105166 |
| Report Source | CONSUMER |
| Date Received | 2017-12-11 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-11-21 |
| Date Added to Maude | 2017-12-11 |
| 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 | 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 | UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2017-12-11 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2017-12-11 |