MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-10-20 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[2248896]
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). Patient experienced severe irritation. Patient's daughter states her mother was hospitalized twice this year because of two different infections related to smith & nephew recall wipes. Patient's daughter discontinued the use of ostomy bag because of severe irritation. Patient was diagnosis with having a c-diff infection and the patient was in the hospital for a few days in (b)(6) 2011. On patient's second visit to the hospital she was diagnosed with having a pulmonary tract infection and was hospitalized for 11 days in (b)(6) 2011. Patient was prescribed levaquin 1000 mg given intravenously three times a day. This medication was prescribed for c-diss and pulmonary tract infection. Antibiotic: metronidazole 500mg taken three times a day for c-diss infection. Patient better and practically healed after discontinuing the use of smith & nephew uni-solve and skin prep wipes.
Patient Sequence No: 1, Text Type: D, B5
[9314955]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "infection-general/systemic". No product was returned by the customer. Other return samples of the reported lot 0h229 were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. Batch records for the lot 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 | 3006760724-2011-00051 |
| MDR Report Key | 2302444 |
| Report Source | 08 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-17 |
| Date of Event | 2011-06-23 |
| Date Mfgr Received | 2011-06-23 |
| Date Added to Maude | 2011-10-20 |
| 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 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 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 |
| Removal Correction Number | 3006760724-04-06-2011-00 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNISOLVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-10-20 |
| Catalog Number | 402300 |
| Lot Number | 0H229 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization | 2011-10-20 |