MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-16 for SKIN PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.
[2199890]
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). Additionally, the lot reported in this incident was produced prior to, and was not subjective to the recall noted. Adverse incident red and painful area that spreads around the abdomen. During visit to er in (b)(6) it was confirmed to be a skin infection. Fever in addition to painful, very red area. Dr. Has recommended blood test to see if it went to the blood stream.
Patient Sequence No: 1, Text Type: D, B5
[9290857]
There were no samples returned by the customer and complaint cannot be confirmed. The samples were not tested since this lot was manufactured by s&n prior to manufacturing transfer, and historical review the product indicates that additional testing is not warranted. The batch record related to this lot 523672 was reviewed and confirmed that the product was manufactured according to the specifications and met all the release criteria. The product was manufactured and released in august 2009. (b)(4) performed to ensure that product is manufactured under clean environment. A review of the (b)(4) indicates that skin irritation under normal use is expected to occur at a frequency of d3 which is 1 in 100,000 and severity is marginal- non-serious injury and significant discomfort. Per the medical and clinical review for similarly associated events, the wipes product is not likely the root cause of the symptoms reported in this complaint. A corrective action has been implemented (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00042 |
| MDR Report Key | 2251029 |
| Report Source | 04 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-05-10 |
| Date Mfgr Received | 2011-05-10 |
| 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 | 0 |
| 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 | 2011-09-16 |
| Model Number | 420400 |
| Lot Number | 523672 |
| 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 33176 US 33176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-16 |