MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for 127566 127566A manufactured by Novo Health Services, Llc.
[127884284]
The double basin had two little holes in the green drape around them. The basin was immediately removed from back table and all the items around it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8088992 |
| MDR Report Key | 8088992 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-30 |
| Report Date | 2018-11-13 |
| Date Reported to FDA | 2018-11-13 |
| Date Reported to Mfgr | 2018-11-20 |
| Date Added to Maude | 2018-11-20 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | KKX |
| Date Received | 2018-11-20 |
| Returned To Mfg | 2018-11-13 |
| Model Number | 127566 |
| Catalog Number | 127566A |
| Lot Number | 600752001 |
| Device Availability | R |
| Device Age | 6 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES, LLC |
| Manufacturer Address | 5155 WESTPARK DR SW ATLANTA GA 30336 US 30336 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |