MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-07-28 for UNI-SOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[2130790]
This (b)(4) complaint was received post smith & nephew's remedial action (voluntary recall) to prevent an unreasonable risk of substantial harm to the public health ((b)(4)). Ulcer things appeared then went away after (b)(6) under doctors care. Patient placed on bag in 1998, and developed urinary tract infection, and subsequently went septic. Patient died on or around (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[9207470]
Active investigation is currently in progress by smith & nephew, as well as a review of the incident details by our medical advisor. Investigation results will be provided in a supplement report once a thorough investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19652405]
The customer did not return any product. We were unable to confirm the complaint since the lot number was not provided and no samples were tested. S&n has manufactured this product at 2 different locations and so without the lot number, the production records cannot be reviewed and further investigation cannot be performed. Control samples (from retains stock) of some lot of uni-solve wipes manufactured by triad were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. An independent medical review of this event indicated that there is no medical evidence to support any relationship between the use of unisolve wipes, and the patient's symptoms and/or subsequent death.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00011 |
| MDR Report Key | 2182827 |
| Report Source | 04 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-27 |
| Date of Event | 2010-04-26 |
| Date Facility Aware | 2011-04-25 |
| Date Mfgr Received | 2011-04-25 |
| Date Added to Maude | 2011-07-29 |
| 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 | 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 |
| Removal Correction Number | 3006760724-04-06-2011-00 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-SOLVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-07-28 |
| Model Number | 402300 |
| Catalog Number | 402300 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Death | 2011-07-28 |