MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-16 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[2199892]
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). In addition, the lot number listed in this event was produced prior to the transfer of manufacturing; therefore the lot noted was not subject to the recall. Adverse event (b)(6) 2010, (b)(6) was admitted to hospital because of diarrhea and left side stomach hurts with sores around stoma; he stayed for a week. In (b)(6) he was admitted to hospital with the same condition, sores around stoma. The hospital treated with fluid and antibiotics. He then returned to hospital in (b)(6) for the 3rd time with the same condition, diarrhea, and sores around the stoma. The dr. Decided it was a bacteria. (b)(6) stayed in for 3 days. They sent him home with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[9345938]
There were no samples returned by the customer and so complaint cannot be confirmed. The batch records for this lot was reviewed and confirmed that product was manufactured and released according to the specifications. (b)(4). The retain samples were not tested since historical review of the product indicates that additional testing is not warranted. There were no changes made to the manufacturing process or ingredients. The s&n production environment was controlled and adequate testing was performed to ensure that product is manufactured under clean environment for safe and efficacious product. Uni-solve adhesive remover is formulated to reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives- hydrocolloid-based, acrylic-based and rubber-based adhesives. The product is comprised of organic solvents and is not conducive to microbial activity. The complaint does not provide any details if the product was used to clean the adhesives or to remove the medical tape. Based on medical and clinical review of similar complaints the wipes product is likely not the root cause of the symptoms reported in this complaint. Recently, prerelease microbial limit testing was added for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00043 |
| MDR Report Key | 2251033 |
| Report Source | 04 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Date Added to Maude | 2011-09-16 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNISOLVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-09-16 |
| Model Number | 402300 |
| Lot Number | 523909 |
| 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. Hospitalization; 2. Other | 2011-09-16 |