MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-24 for SKIN-PREP WIPES BOX 50 01 420400 manufactured by Smith & Nephew Wound Management.
[10169717]
There was no product was returned by the customer and so the complaint could not be confirmed. The production records could not be reviewed for this investigation since no lot number was provided. 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 the product to dry thoroughly before any device is applied. The isopropyl alcohol is known irritant. The alcohol content may contribute to drying of the skin. So patients are instructed to avoid trauma to the area and to avoid the use of alcohol and sensitizing agents. Sometimes skin irritation and reactions are expected to occur and severity is marginal with non-serious injury and significant discomfort. An independent medical review of this complaint confirmed that skin prep wipes is not the root cause of the issue. The medical review confirmed that the development of a urinary tract infection is a distinct possibility after an operative procedure, especially in a patient who is catheterized. The medical review confirmed there is no indication in the records whether the patient had a urinary catheter at the time of his orthopedic procedure, what the urinary cultures showed or the antibiotics that were administered. We were unable to determine a specific root cause for this issue; however, we will continue to monitor the complaints system for similar events. Given that product has sufficient warnings and that it has been relocated, no further corrective actions will be taken for this complaint.
Patient Sequence No: 1, Text Type: N, H10
[17098210]
In (b)(6) 2011, patient taken by ambulance to hospital. Spent three days in icu diagnosed with urinary sepsis.
Patient Sequence No: 1, Text Type: D, B5
[17183100]
In accordance with the provisions of 21cfr803. 50, we are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a serious and unexpected adverse event which occurred while using no sting skin-prep wipes. Active investigation in progress; awating hippa release of medical information, and sample returns from customer for lab testing. Results of investigation will be submitted in a supplement report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2012-00002 |
| MDR Report Key | 2546925 |
| Report Source | 04 |
| Date Received | 2012-04-24 |
| Date of Report | 2012-04-24 |
| Date Mfgr Received | 2012-03-26 |
| Date Added to Maude | 2012-04-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 50 01 |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2012-04-24 |
| Model Number | 420400 |
| Lot Number | UNKNOWN |
| 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 | 2012-04-24 |