MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-22 for UNI-SOLVE 402300 manufactured by Smith & Nephew Wound Management.
[2168249]
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 #(b)(4)). Patient hospitalized twice in 2011. First hospital visit (b)(6) 2011 for 14 - 18 days. Patient diagnosed with having an infection in her right lung. Second hospital visit patient admitted (b)(6) 2011 and discharged after 12 days. Patient diagnosed with having an infection in her left lung and right arm. Patient states she had a fever constantly for months.
Patient Sequence No: 1, Text Type: D, B5
[9397824]
Active investigation in progress; investigation results to be provided in supplement report.
Patient Sequence No: 1, Text Type: N, H10
[20210627]
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. For lot 513683, about (b)(4) wipes were manufactured and released by s&n in (b)(4) 2007. Review of previous complaints for this lot confirmed that production records met all the release specifications. There were 2 complaints reported in 2008 for leaking product. The current shelf life of this product is 5 years. 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 wipe 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. There has been no other complaint reported for this product lot and some adverse events have been reported for this product code. The risk register ramr does not have risk identified for conditions in this incident. Ramr does indicate that skin irritation under normal use is expected to occur at a frequency of d3 which is 1 in 100,000 and severity is marginal- non-serious injury and significant discomfort. The complaint does not provide any details on how the product was being used by the patient. Per the medical and clinical review of similar complaints with this product, the wipes product is likely not the root cause of the symptoms reported in this complaint. Also it is very likely that the patient returned this product thinking that this lot is part of the triad recall. Recently, prerelease microbial limit testing was added for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00023 |
| MDR Report Key | 2218237 |
| Report Source | 04 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-08-19 |
| Date of Event | 2011-08-09 |
| Date Facility Aware | 2011-08-09 |
| Date Mfgr Received | 2011-08-09 |
| Date Added to Maude | 2012-06-11 |
| 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 | 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 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 | UNI-SOLVE |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-08-22 |
| Model Number | 402300 |
| Lot Number | 513683 |
| Device Availability | N |
| Device Age | DA |
| 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 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-08-22 |