MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-30 for IV PREP WIPES 59421200 manufactured by Smith & Nephew, Inc..
[27090588]
Patient Sequence No: 1, Text Type: N, H10
[27090589]
It was reported that there is not much adhesive on the iv prep pads. As a result, the patient has suffered torn skin and/ or irritated skin precisely where the iv prep was applied.
Patient Sequence No: 1, Text Type: D, B5
[37852777]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00093 |
| MDR Report Key | 5113187 |
| Report Source | CONSUMER |
| Date Received | 2015-09-30 |
| Date of Report | 2015-09-25 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-09-30 |
| 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 | 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 |
| Generic Name | DEGREASER, SKIN, SURGICAL |
| Product Code | KOY |
| Date Received | 2015-09-30 |
| Returned To Mfg | 2015-10-05 |
| Catalog Number | 59421200 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 11 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-30 |