MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-13 for IV PREP WIPES BOX OF 50 59421200 manufactured by Smith & Nephew, Inc..
[22875885]
Patient Sequence No: 1, Text Type: N, H10
[22875886]
It was reported that 3 months ago that while using the product, the patient experienced blisters, itchy and fluid oozing form the wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006760724-2015-00075 |
| MDR Report Key | 5000841 |
| Report Source | CONSUMER |
| Date Received | 2015-08-13 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-08-13 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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, INC. |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV PREP WIPES BOX OF 50 |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2015-08-13 |
| Model Number | 59421200 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |