MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-02-28 for SKIN-PREP WIPES BOX 420400 manufactured by Smith & Nephew Wound Management.
[3170865]
Skin prep wipes thought to be contaminated with bacillus cereus. After using the wipes, the patient experienced a bacterial infection which resulted in death.
Patient Sequence No: 1, Text Type: D, B5
[10577303]
Samples have not been returned to smith & nephew for evaluation. Investigation into retain batch records show that independent microbiological tests were conducted on the retains for the lot reported. There was no evidence of microbiological contamination found in the retain samples. An active investigation is currently in progress and the results of our investigation will be detailed in a supplement report.
Patient Sequence No: 1, Text Type: N, H10
[10622742]
Smith & nephew has completed their investigation into the reported incident. After a thorough investigation we were unable to confirm any causal relationship, or device failure as having caused or contributed to the event reported. An independent medical review of similar complaints confirmed that skin prep wipes is not the root cause of the issue. There was no product was returned by the customer so no testing could be performed on customer samples. However, the retain samples of this lot were analyzed by an independent analytical lab and no microbial contamination or growth was noted. Skin prep wipes is an isopropyl alcohol based liquid film-forming skin preparation that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. Per the product labeling, it is very important to allow to dry thoroughly before any device is applied. We were unable to determine a specific root cause for this issue. Given that product has sufficient warnings and that it has been relocated, no further investigation, or corrective actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2013-00002 |
| MDR Report Key | 2983584 |
| Report Source | 00 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2011-02-09 |
| Date Mfgr Received | 2013-02-28 |
| Date Added to Maude | 2013-03-01 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| 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 BOX |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2013-02-28 |
| Model Number | 420400 |
| Lot Number | 0L165 |
| 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. Death | 2013-02-28 |