MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-09-23 for WEBRIL UNDRCST PAD 4"X4YD NON ST 3175 manufactured by Covidien Lp, Formerly Registered As Kendall.
[15212014]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with undercast padding. The customer stated the padding is pulling apart easily and is flaking into the wound.
Patient Sequence No: 1, Text Type: D, B5
[15794306]
(b)(4). An investigation is currently underway upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2011-00019 |
| MDR Report Key | 2307582 |
| Report Source | 06,07 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-09 |
| Date of Event | 2011-09-09 |
| Date Facility Aware | 2011-09-09 |
| Report Date | 2011-09-09 |
| Date Mfgr Received | 2011-09-09 |
| Date Added to Maude | 2011-12-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616387 |
| Manufacturer G1 | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
| Manufacturer Street | 1430 MARVIN GRIFFIN RD. |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEBRIL UNDRCST PAD 4"X4YD NON ST |
| Generic Name | UNDERCAST PADDING |
| Product Code | ITG |
| Date Received | 2011-09-23 |
| Returned To Mfg | 2011-09-21 |
| Model Number | 3175 |
| Catalog Number | 3175 |
| Lot Number | 11000195366ZX |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD. AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-23 |