MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-14 for DISPOSABLE TRE COR'L, 8.0-9.0 MM E3174-7 manufactured by Storz Instrument Co..
[8977]
Possible safety cover malfunctioned during removal. Rubber plug was left in tube and caused corneal abrasion on transplanted cornea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002815 |
| MDR Report Key | 14676 |
| Date Received | 1994-07-14 |
| Date of Report | 1994-07-01 |
| Date of Event | 1994-06-30 |
| Date Added to Maude | 1994-07-15 |
| 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 | DISPOSABLE TRE COR'L, 8.0-9.0 MM |
| Product Code | HRH |
| Date Received | 1994-07-14 |
| Catalog Number | E3174-7 |
| Lot Number | NA |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14670 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | ST LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-14 |