MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-16 for SKIN PREP 4.25OZ SPR 420200 manufactured by Smith & Nephew, Inc..
[33616729]
Patient Sequence No: 1, Text Type: N, H10
[33616730]
Adverse skin reaction was reported whilst using this product, skin became itchy. Wafer had to be removed due to pruritus and rash was noted. Product had been used beyond expiration date of 02/2012.
Patient Sequence No: 1, Text Type: D, B5
[46257391]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2015-00120 |
| MDR Report Key | 5301942 |
| Report Source | CONSUMER |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-07 |
| Date of Event | 2015-12-05 |
| Date Mfgr Received | 2015-12-07 |
| Date Added to Maude | 2015-12-16 |
| 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 |
| 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 G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 970 LAKE CARILLON DRIVE |
| 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 | SKIN PREP 4.25OZ SPR |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT. |
| Product Code | NEC |
| Date Received | 2015-12-16 |
| Model Number | 420200 |
| Catalog Number | 420200 |
| Lot Number | 522114 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 970 LAKE CARILLON DRIVE ST PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-16 |