MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-09 for CIRCLING BAND 240-STYLE 2.5 E5381700 manufactured by Storz Instrument Company.
[20769889]
After one of these bands had been implanted, the dr noticed it appeared cracked. He removed the band and replaced it with another one. There were no pt problems. The band was disposed of. There is no product to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1998-00006 |
| MDR Report Key | 143704 |
| Report Source | 05,06 |
| Date Received | 1998-01-09 |
| Date of Report | 1997-12-10 |
| Date of Event | 1997-12-10 |
| Date Facility Aware | 1997-12-10 |
| Report Date | 1997-12-10 |
| Date Reported to Mfgr | 1997-12-11 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1998-01-15 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCLING BAND 240-STYLE 2.5 |
| Generic Name | IMPLANT FOR RETINAL DETACHMENT SURGERY |
| Product Code | HQX |
| Date Received | 1998-01-09 |
| Model Number | NA |
| Catalog Number | E5381700 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140159 |
| Manufacturer | STORZ INSTRUMENT COMPANY |
| Manufacturer Address | 3365 TREE COURT IND BLVD ST. LOUIS MO 63122 US |
| Baseline Brand Name | CIRCLING BAND 240-STYLE 2.5 |
| Baseline Generic Name | IMPLANT FOR RETINAL DETACHMENT SURGERY |
| Baseline Model No | NA |
| Baseline Catalog No | E5381700 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-09 |