MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-23 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[2167837]
This unisolve complaint was received post smith & nephew's remedial action (voluntary recall) to prevent an unreasonable risk of substantial harm to the public health (ref. Recall #3006760724-04-06-2011-001r). Adverse incident patient developed a rash around the stoma area. Patient originally thought his rash was caused from glue on a tape he uses. Patient wife stated her husband had a breakdown of his skin after surgery (b)(6) 2006. Patient started using uni-solve adhesive remove wipes after his surgery dated (b)(6) 2006. Patient was taken to the emergency room several times in due to rash on around stoma.
Patient Sequence No: 1, Text Type: D, B5
[9260388]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "skin irritation/reaction". The customer sent in some product samples. We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. All of the returned sample(s) of lots 0f195, 0f239, 0k207, 0k233, 0m151 as well as control samples (from stock) of additional lots of uni-solve wipes were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. Batch records for the lots indicate all specifications were met at the time of release and no inconsistencies were noted. An independent medical review concluded there was no correlation between the reported symptoms and the use of uni-solve wipes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00031 |
| MDR Report Key | 2220772 |
| Report Source | 04 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-05-02 |
| Date of Event | 2011-05-02 |
| Date Mfgr Received | 2011-05-02 |
| Date Added to Maude | 2011-08-24 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer G1 | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNISOLVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-08-23 |
| Model Number | 402300 |
| Lot Number | 0F195 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33176 US 33176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-23 |