MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-25 for SKIN PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2151372]
Complainant's husband died (b)(6) 2010; cause of death - cancer. However, patient's wife feels there is a possibility her husband's death is related to smith & nephew wipes.
Patient Sequence No: 1, Text Type: D, B5
[9364848]
Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "adverse incident". There were no samples returned by the customer and so complaint cannot be confirmed. As no lot number was provided control samples could not be tested, and supplier investigation and production records review could not be performed. An independent medical review of this complaint indicated that the medical evidence in this case is insufficient to suggest any relationship between the use of skin-prep wipes and the patient's death. Since the lot number was not provided, further investigation cannot be performed. The product is intended for use as a film-forming product which upon application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive dressings, drainage tubes, external catheters, and surrounding ostomy sites. It is designed to be used to reduce risk of irritation due to friction. It is very critical that the solvent is allowed to dry completely before any device is applied. Sometimes skin irritation under normal use is expected to occur and severity is low- non-serious injury and significant discomfort. Additionally, if sufficient product is not applied, it is likely that it may result poor adhesion of device causing tracts for local infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00057 |
| MDR Report Key | 2306945 |
| Report Source | 04 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-07-27 |
| Date Mfgr Received | 2011-07-27 |
| Date Added to Maude | 2011-10-25 |
| 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 | SKIN PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-10-25 |
| Catalog Number | 420400 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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. Death | 2011-10-25 |