MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for HALYARD DISPERSIVE ELECTRODE P60-FMA-GF-BAY manufactured by Halyard Health / Avanos Medical, Inc..
| Report Number | MW5089607 |
| MDR Report Key | 8970780 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-08-06 |
| Date Added to Maude | 2019-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HALYARD DISPERSIVE ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2019-09-05 |
| Model Number | P60-FMA-GF-BAY |
| Catalog Number | P60-FMA-GF-BAY |
| Lot Number | 201809255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH / AVANOS MEDICAL, INC. |
| Manufacturer Address | ALPHARETTA GA US |
| Brand Name | HALYARD DISPERSIVE ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2019-09-05 |
| Model Number | P60-FMA-GF-BAY |
| Catalog Number | P60-FMA-GF-BAY |
| Lot Number | 201809255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH / O & M HALYARD, INC. |
| Manufacturer Address | ALPHARETTA GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-05 |