MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-07-18 for UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT WD054 manufactured by Smith & Nephew Wound Management.
[3577964]
Legal claim received by smith & nephew purports that the wipes were defective or contaminated, and as a result caused severe and permanent injuries.
Patient Sequence No: 1, Text Type: D, B5
[10996832]
.
Patient Sequence No: 1, Text Type: N, H10
[21404580]
The customer did not return any product and so the complaint could not be confirmed. The batch record review and supplier investigation could not be done since s&n no longer manufactures the product with triad. The complaint is against skin prep or remove. The retain samples of products could not be tested since no lot number was provided. Some retains samples for both products made at (b)(4) were tested and no evidence of contamination was found. There is no detailed description of the injuries e. G. Rash, irritation, etc. Noted by the user. Since there were no samples and no specific part number and/or lot number was provided, we were unable to determine a specific root cause for this issue. At this time no further action is needed since product has sufficient warning and there are no trends noted. Similar complaints on smith & nephew products have been previously investigated, however independent medical review concluded that smith & nephew products are not related to any of the similarly reported issues. In the absence of product samples and/or part number, lot/batch number details conclusive investigation results, or a definitive connection to any smith & nephew products cannot be determined at this time. No further investigation and/or corrective action will be conducted at this time. Smith & nephew will continue to monitor for any trends on any of our products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2013-00008 |
| MDR Report Key | 3232968 |
| Report Source | 00 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-07-17 |
| Date Mfgr Received | 2013-06-18 |
| Date Added to Maude | 2013-07-18 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2013-07-18 |
| Model Number | WD054 |
| Lot Number | UNKNOWN |
| 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. Other; 2. Deathisabilit | 2013-07-18 |