MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-09-16 for IV PREP WIPES 79471 manufactured by Smith & Nephew Wound Management.
[9557314]
The customer did not return any product and no lot number was provided. The complaint could not be confirmed. Since no lot number was provided, the manufacturing location of the product could not be determined; hence laboratory testing or the results were available for review. S&n has manufactured this product at 3 different manufacturers in the last 3 years. The control samples for all 20 lots of iv prep wipes manufactured by triad were tested and it met all product specifications with no evidence of microbial contamination found. Batch records for the all the 20 lots indicate all specifications were met at the time of release and no inconsistencies were noted. We were unable to determine a specific root cause for this issue. Since contamination was not present throughout the entire lot of product, this appears to have been an isolated incident. The customer did not provide adequate information and so thorough independent medical review of the incident could not be performed. However, independent medical review of similar complaints with this product concluded there was no correlation between the reported symptoms and the use of iv prep wipes.
Patient Sequence No: 1, Text Type: N, H10
[17413916]
This iv 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 #3006760724-030211-001r). Mr. (b)(6) wife, (b)(6) had died and he believes the cause of her death is the wipes she was using. He would not give lot numbers or specifics on which products she was using. Initial reporter (distributor) has indicated that there are other potential reasons which resulted in the death.
Patient Sequence No: 1, Text Type: D, B5
[17815964]
Based on current available information which was provided by the distributor; it is not suspected that iv-prep wipes either caused or contributed to this event. Active investigation in progress; results of investigation to be provided in a supplement report. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00041 |
| MDR Report Key | 2250801 |
| Report Source | 08 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-05-31 |
| Date Facility Aware | 2011-05-31 |
| Date Mfgr Received | 2011-05-31 |
| Date Added to Maude | 2011-09-16 |
| 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 | IV PREP WIPES |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2011-09-16 |
| Model Number | 79471 |
| 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 | 2011-09-16 |