MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2015-06-30 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew, Inc..
[6057730]
It was reported that a patient experienced puffy skin with red dots (where the tape was present) that looked to be possible filled with puss within 4 hours of use of the product. The patient visited the emergency room where she was seen and treated prophylactically with an antibiotic. She previously was put on antibiotics for an infection following a gastrointestinal surgery and as a result is wearing a wound vac. The reaction was noticed during a dressing a change. The wound vac was removed and the reaction appears to be drying out.
Patient Sequence No: 1, Text Type: D, B5
[13700210]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00064 |
| MDR Report Key | 4878758 |
| Report Source | 04,07 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-20 |
| Date Mfgr Received | 2015-06-24 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Event Location | 0 |
| 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 | UNISOLVE WIPES |
| Generic Name | UNI-SOLVE WIPES BX 50 ADH REM |
| Product Code | KOX |
| Date Received | 2015-06-30 |
| Catalog Number | 402300 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2015-06-30 |