MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-01-10 for SILICONE TIRE IMPLANT 287-STYLE FOR RETINAL DETACHMENT E5381 721 manufactured by Storz Instrument Co..
[43094]
When the package was opened for used during an ophthalmic procedure, there was no silicone tire enclosed; the package was empty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1997-00021 |
| MDR Report Key | 63970 |
| Report Source | 08 |
| Date Received | 1997-01-10 |
| Date of Report | 1996-12-13 |
| Date of Event | 1996-12-13 |
| Date Facility Aware | 1996-12-13 |
| Report Date | 1996-12-13 |
| Date Reported to Mfgr | 1996-12-13 |
| Date Mfgr Received | 1996-12-13 |
| Device Manufacturer Date | 1987-12-01 |
| Date Added to Maude | 1997-01-24 |
| 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 | SILICONE TIRE IMPLANT 287-STYLE FOR RETINAL DETACHMENT |
| Generic Name | RETINAL DETACHMENT IMPLANT |
| Product Code | HQX |
| Date Received | 1997-01-10 |
| Model Number | NA |
| Catalog Number | E5381 721 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 64118 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE COURT INDL BLVD. ST. LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-10 |