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 |