MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-17 for SKIN PREP WIPES manufactured by Smith & Nephew, Inc..
[6053692]
It was reported that the patient experienced pulling off of the skin as the product was being removed. At the time of this report, the patient is said to be recovering and no hospitalization was required.
Patient Sequence No: 1, Text Type: D, B5
[14382307]
Patient Sequence No: 1, Text Type: N, H10
[42525574]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00068 |
| MDR Report Key | 4922234 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-16 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2015-07-16 |
| Date Added to Maude | 2015-07-17 |
| 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 | MR. TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273993785 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIN PREP WIPES |
| Generic Name | SKIN-PREP WIPES BOX 50 01 |
| Product Code | NEC |
| Date Received | 2015-07-17 |
| Lot Number | 420400 |
| 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, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-17 |