MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-21 for SKIN PREP WIPES 59420425 manufactured by Smith & Nephew, Inc..
[36460714]
Patient Sequence No: 1, Text Type: N, H10
[36460715]
It was reported a patient had eczema, suspected to be caused by the skin-prep wipes and universal remover wipes. Following epicutaneous testing, these reactions have been assessed to be allergic contact dermatitis.
Patient Sequence No: 1, Text Type: D, B5
[46809793]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2016-00002 |
| MDR Report Key | 5382151 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-21 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2015-12-17 |
| Date Added to Maude | 2016-01-21 |
| 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 |
| 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 WIPES |
| Generic Name | SKIN-PREP WIPES CTN 50 |
| Product Code | KMF |
| Date Received | 2016-01-21 |
| Model Number | 59420425 |
| Catalog Number | 59420425 |
| ID Number | X |
| 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 | 2016-01-21 |