MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-30 for IV PREP WIPES BOX OF 50 59421200 manufactured by Smith & Nephew Medical Ltd.
[34641145]
Patient Sequence No: 1, Text Type: N, H10
[34641146]
Inconsistent product quality has been reported, with failure to protect skin. The patient has reportedly developed rashes, redskin and blisters. It is reported that the patients skin was so itchy and sore that it is very difficult for them to concentrate.
Patient Sequence No: 1, Text Type: D, B5
[49969648]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00124 |
| MDR Report Key | 5334155 |
| Report Source | CONSUMER |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-30 |
| 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 | MRS CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer Phone | 0628320660 |
| Manufacturer G1 | CLIFFORD BENNET |
| Manufacturer Street | SPAN PACKAGING SERVICES, LLC. 4611 DAIRY ROAD, |
| Manufacturer City | SUITA A, GREENVILLE, SC 29607 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29607 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV PREP WIPES BOX OF 50 |
| Generic Name | SKIN PREP WIPES |
| Product Code | NEC |
| Date Received | 2015-12-30 |
| Model Number | 59421200 |
| Catalog Number | 59421200 |
| Lot Number | 6869 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD |
| Manufacturer Address | 101 HESSLE ROAD SUITE 110 HULL FL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2015-12-30 |