MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for 101816C manufactured by Novo Health Services, Llc.
[134988840]
During set up of the case, the operating room tech spotted a hair that was under the dust cover of a sterile product. The package was not opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8304310 |
| MDR Report Key | 8304310 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-01-24 |
| Date of Event | 2019-01-24 |
| Report Date | 2019-01-24 |
| Date Reported to FDA | 2019-01-24 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| 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 | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-02-05 |
| Returned To Mfg | 2019-01-24 |
| Catalog Number | 101816C |
| Lot Number | 608018001 |
| Device Availability | R |
| Device Age | 10 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES, LLC |
| Manufacturer Address | 2595 CUSTER ROAD, SUITE B SALT LAKE CITY UT 84104 US 84104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |