MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 1996-11-01 for STORZ BARRAQUER EYE SPECULUM E4106S manufactured by Storz Instrument Co..
[32807]
This eye speculum broke at the blade during a prk procedure. Another instrument was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1996-00098 |
| MDR Report Key | 46845 |
| Report Source | 00,06 |
| Date Received | 1996-11-01 |
| Date of Report | 1996-09-20 |
| Date of Event | 1996-09-16 |
| Date Facility Aware | 1996-09-16 |
| Report Date | 1996-09-20 |
| Date Reported to Mfgr | 1996-09-20 |
| Date Mfgr Received | 1996-09-20 |
| Date Added to Maude | 1996-11-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ BARRAQUER EYE SPECULUM |
| Generic Name | EYE SPECULUM |
| Product Code | HNC |
| Date Received | 1996-11-01 |
| Model Number | NA |
| Catalog Number | E4106S |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 47655 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN COURT ST LOUIS MO 63011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-01 |