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.
[9574877]
There were no samples returned by the customer and so complaint cannot be confirmed. Some retain samples of some skin prep wipes lots manufactured by this supplier were tested and no evidence of microbial growth was noted. Other return samples of the reported lot 0d200 from other complaints were analyzed by an independent test laboratory and met finished product specifications with no evidence of microbial contamination found. Batch records for the lot indicate all specifications were met at the time of release and no inconsistencies were noted. Skin prep 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. Medical review of this complaint confirmed that the reported symptoms cannot be attributed to the use of s&n wipes product.
Patient Sequence No: 1, Text Type: N, H10
[20734217]
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 hospitalized twice in 2011. First hospital visit (b)(6) 2011 for 14 - 18 days. Patient diagnosed with having an infection in her right lung. Second hospital visit patient admitted (b)(6) 2011 and discharged after 12 days. Patient diagnosed with having an infection in her left lung and right arm. Patient states she had a fever constantly for months.
Patient Sequence No: 1, Text Type: D, B5
[20911743]
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 | 3006760724-2011-00022 |
| MDR Report Key | 2218234 |
| Report Source | 04 |
| Date Received | 2011-08-22 |
| Date of Report | 2011-08-19 |
| Date of Event | 2011-08-09 |
| Date Mfgr Received | 2011-08-09 |
| 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 | 0D200 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-08-22 |