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 SKIN-PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2263629]
This skin prep 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 #3006760724-04-06-2011-001r). Patient death in this incident occurred in (b)(6), 2010; smith & nephew was first notified of this event in (b)(6), 2011. Patient, (b)(6), had a lung transplant (b)(6) 2010. Patient died due to pneumonia fibrosis and an infection (b)(6) 2010. Patient's daughter states her father (b)(6) used smith & nephew products and wonder if his death is related to the recall items. Patient daughter states her father had an unknown infection at the time of his death. Patient daughter stated wipes were thrown away when her father died (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[9258360]
Active investigation in progress; results of investigation will be provided in a supplement report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21518780]
The customer did not return any product. We were unable to confirm the complaint since the lot number was not provided. S&n has manufactured this product at 2 different suppliers in the last 3 years and so without the lot number, the production records cannot be reviewed. Control samples (from stock) of some lots of skin prep manufactured by triad were analyzed by an independent test laboratory and met finished product specifications with some microbial growth in one of the lots. The microbiologist assessment of those samples with microbial growth concluded that the risk is none. An independent medical review concluded there was no correlation between the reported symptoms and the use of skin prep wipes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00021 |
| MDR Report Key | 2218239 |
| Report Source | 04 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-08-19 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2011-04-28 |
| Date Added to Maude | 2011-08-22 |
| 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 | SKIN-PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-08-22 |
| Model Number | 420400 |
| Lot Number | UNKNOWN |
| 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. Death | 2011-08-22 |