MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for 179775P manufactured by Covidien.
[44552449]
(b)(4). The reported devices is labeled for single use. The device was not reprocessed and reused. No remedial action was taken.
Patient Sequence No: 1, Text Type: N, H10
[44552450]
This report summarizes 1 malfunction events which are associated with undesired damage or breakage of materials used in device construction. No patient information confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2016-00086 |
| MDR Report Key | 5612585 |
| Date Received | 2016-04-27 |
| Date Added to Maude | 2016-04-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2016-04-27 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-27 |