MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2011-09-16 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[19909735]
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 experiencing pain in lungs. Recently discharged from hospital, diagnosed with having (b)(6). Three hospital visits since using uni-solve wipes, from (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[19944942]
There were no samples returned by the customer and so complaint cannot be confirmed. The batch records for these lots were reviewed and confirmed that product was manufactured and released according to the specifications. Lot 0050 was manufactured by (b)(4) and released in april/ may 2011 and lot 523633 was manufactured and released in july 2009. (b)(4). There were no changes made to the manufacturing process or ingredients. Additionally microbial limit testing was performed on this lot 0050 prior to release and confirmed that product was negative for e-coli. The product is comprised of organic solvents and is not conducive to microbial activity. 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. Some other adverse event complaints have been reported for this lot code. There is not enough information in the complaint to determine where this product was used and so (b)(4) assessment for risk is difficult. (b)(4). Medical and clinical reviews conducted for similarly related events have concluded that the wipes product is likely not the root cause of the symptoms reported in this complaint. Given that this is an isolated incident with this lot code and this issue, there is no other corrective action warranted on this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00044 |
| MDR Report Key | 2251027 |
| Report Source | * |
| 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 | 0 |
| 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 | 0050 |
| 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 | 2011-09-16 |