MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-13 for UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT manufactured by Smith & Nephew Wound Management.
[3548285]
Patient was alleged to have been infected by a bacterial-contaminated alcohol pad he used to sanitize his skin to assist in the healing of the wound on his thigh. As a result, he was hospitalized and underwent numerous treatments to overcome, and attempt to eradicate the infection from the bacteria. Patient suffered greatly from a wound infection which led to a leg amputation and ultimately to his death on (b)(6) 2011. Smith & nephew was first notified of this incident on (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10782347]
Investigation is currently in progress. The initial reporter did not indicate a specific part number, product name, lot number or samples for evaluation. Investigation results will be provided in a supplement report.
Patient Sequence No: 1, Text Type: N, H10
[19211688]
There were no samples provided and the complaint could not be confirmed. The supplier investigation was not performed on this complaint since no lot number was provided, and therefore, no detailed batch record review is possible. The complaint description references alcohol pads as the product in use by the customer to sanitize the skin, and therefore, it could not be conclusively determined whether this event was related to the use of any smith & nephew products. 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 | 3006760724-2013-00007 |
| MDR Report Key | 3168458 |
| Report Source | 04 |
| Date Received | 2013-06-13 |
| Date of Report | 2013-06-12 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2013-05-16 |
| Date Added to Maude | 2013-06-13 |
| 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 | UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2013-06-13 |
| 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 | 2013-06-13 |