MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-25 for SKIN-PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2164291]
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). Adverse incident, ms. (b)(6) was initially hospitalized on (b)(6), 2010 with a bacterial infection (b)(6). She was hospitalized for about 5 days, treated with antibiotics including penicillin.
Patient Sequence No: 1, Text Type: D, B5
[9399462]
Active investigation in progress; results of investigation will be provided in a supplement report. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[15798210]
We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. Both the returned samples of lot 0d200 as well as control samples (from stock) of reported lot 0j85 met finished product specifications and no evidence of microbial contamination was found. However, low levels of a nonpathogenic bacterium, bacillus flexus, was detected during analysis of the return sample of lot 0j85. This species of bacteria is often isolated in clean room environments and is not known to cause illness or infection in healthy individuals. To date, there have been no other reports of contamination by this organism for this lot of product. Batch records for both the reported 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. 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 | 3006760724-2011-00034 |
| MDR Report Key | 2222498 |
| Report Source | 04 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-24 |
| Date of Event | 2011-05-03 |
| Date Facility Aware | 2011-05-03 |
| Date Mfgr Received | 2011-05-03 |
| Date Added to Maude | 2011-08-25 |
| 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 | 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 | 2011-08-25 |
| Model Number | 420400 |
| Lot Number | 0D200 |
| Device Availability | Y |
| 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. Hospitalization | 2011-08-25 |