MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-25 for DIAMOND KNIFE OP9710 manufactured by Kmi Corp.
[15615762]
It was reported that the product came off in the pt's eye. The piece was retrieved during the same procedure. The reporter stated that pt injury did not occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416557-1993-00002 |
| MDR Report Key | 24296 |
| Date Received | 1994-01-25 |
| Date of Report | 1993-12-13 |
| Date Facility Aware | 1993-12-01 |
| Report Date | 1993-12-13 |
| Date Reported to Mfgr | 1993-12-09 |
| Date Added to Maude | 1995-08-10 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMOND KNIFE |
| Generic Name | SURGICAL KNIFE |
| Product Code | EMF |
| Date Received | 1994-01-25 |
| Returned To Mfg | 1993-12-09 |
| Model Number | NA |
| Catalog Number | OP9710 |
| Lot Number | 11004 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24661 |
| Manufacturer | KMI CORP |
| Manufacturer Address | 889 SOUTH MATLACK STREET WEST CHESTER PA 19382 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-25 |