MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for OPMI? DRAPES STERILE 306026-0000-000 manufactured by Carl Zeiss Meditec Ag.
[129754291]
Hair was found in the package before it was opened in the operating room. It was found in the opmi drapes sterile package manufactured by carl zeiss (b)(4). There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8145988 |
| MDR Report Key | 8145988 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-12-04 |
| Report Date | 2018-12-05 |
| Date Reported to FDA | 2018-12-05 |
| Date Reported to Mfgr | 2018-12-10 |
| Date Added to Maude | 2018-12-10 |
| 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 |
| Brand Name | OPMI? DRAPES STERILE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2018-12-10 |
| Model Number | 306026-0000-000 |
| Catalog Number | 306026-0000-000 |
| Lot Number | D180092A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | 5160 HACIENDA DRIVE DUBLIN CA 94568 US 94568 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-10 |