MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-29 for SKIN PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2327423]
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 rash appeared around stoma. Consequential hospital stay for 6 days. Antibiotics prescribed though unwell feeling persisted.
Patient Sequence No: 1, Text Type: D, B5
[9404374]
Active investigation in progress; investigation results will be submitted in a supplement report. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[9572438]
The customer returned some samples which were tested by an independent test laboratory for microbial limit testing which showed some microbial growth and the identification testing confirmed it to be (b)(6). Control samples (from stock) of skin prep lot 0l225 were analyzed by the same independent test laboratory and some microbial growth was seen which was identified as bacillus methylotrophicus. For both samples, the counts of the actual growth were well below the allowable limits for a preserved, non-sterile skin-prep product. The microbiologist assessment of those samples with microbial growth concluded that the risk is none. An independent medical review of the lab results and complaint details concluded there was no correlation between the reported symptoms, and the bacterial growth identified on the customer samples.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00038 |
| MDR Report Key | 2225900 |
| Report Source | 04 |
| Date Received | 2011-08-29 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-05-16 |
| Date Mfgr Received | 2011-05-16 |
| Date Added to Maude | 2011-08-30 |
| 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 | 2011-08-29 |
| Model Number | 420400 |
| Lot Number | 0D190 |
| 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 | 2011-08-29 |