MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-21 for WEBRIL II 100% COTTON UNDERCAST PADDING * 2847 manufactured by Covidien Lp, Formerly Registered As Kendall.
[21047568]
Stains on webril cotton undercast padding insterile wraper. ======================manufacturer response for cotton undercast padding, webril (per site reporter). ======================i have contacted both customer services and the rep with no reply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2934582 |
| MDR Report Key | 2934582 |
| Date Received | 2013-01-21 |
| Date of Report | 2013-01-14 |
| Date of Event | 2013-01-07 |
| Report Date | 2013-01-14 |
| Date Reported to FDA | 2013-01-21 |
| Date Added to Maude | 2013-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEBRIL II 100% COTTON UNDERCAST PADDING |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2013-01-21 |
| Model Number | * |
| Catalog Number | 2847 |
| Lot Number | 120002183662X |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-21 |