MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-17 for CORNEAL TREPHINE, 9.5 manufactured by Storz Instrument Co..
[16145679]
Pt had surgery 4/26/94 for corneal transplant. Physician noted foreign body in eye on 4/27/94. Consult called with another physician to examine pt. Confirmed metal shaving in eye. Pt returned to surgery 4/28/94 for removal of foreign body. Device secured in risk mgmt dept.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001998 |
| MDR Report Key | 13276 |
| Date Received | 1994-05-17 |
| Date of Report | 1994-04-29 |
| Date of Event | 1994-04-26 |
| Date Added to Maude | 1994-05-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORNEAL TREPHINE, 9.5 |
| Generic Name | CORNEAL TREPHINE |
| Product Code | HOF |
| Date Received | 1994-05-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13274 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | ST LOUIS MO 631958678 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-05-17 |