MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for STORZ manufactured by Storz Instruments.
[11921]
Pt. To surgery 4/26/94 for corneal transplant. Physician noted foreign body in eye on 4/27/94. Consult called with another physician to examine. Confirmed metal shaving in eye. Pt. Returned to surgery 4/28/94 for removal of foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 19230 |
| MDR Report Key | 19230 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-04-29 |
| Date of Event | 1994-04-26 |
| Date Added to Maude | 1995-01-30 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | STORZ |
| Generic Name | CORNEAL TREPHINE |
| Product Code | HOF |
| Date Received | 1994-07-29 |
| Lot Number | REUSABLE |
| ID Number | 9.5 CORNEAL TREPHINE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13274 |
| Manufacturer | STORZ INSTRUMENTS |
| Manufacturer Address | P.O. BOX 18678M ST. LOUIS MO 631058678 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |