MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-12-29 for SILICONE STRIP (219 STYLE) E5381 700 manufactured by Storz Instrument Co..
[7766194]
A device recall was initiated for this product on 1/6/1998.
Patient Sequence No: 1, Text Type: N, H10
[18137345]
This circling band disintegrated while the dr was trying to use it. There was no effect on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-1997-00560 |
| MDR Report Key | 141136 |
| Report Source | 05,06 |
| Date Received | 1997-12-29 |
| Date of Report | 1997-12-04 |
| Date of Event | 1997-12-04 |
| Date Facility Aware | 1997-12-04 |
| Report Date | 1997-12-04 |
| Date Reported to Mfgr | 1997-12-04 |
| Date Mfgr Received | 1997-12-04 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1998-01-05 |
| 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 | SILICONE STRIP (219 STYLE) |
| Generic Name | RETINAL DETACHMENT IMPLANT |
| Product Code | HQX |
| Date Received | 1997-12-29 |
| Model Number | NA |
| Catalog Number | E5381 700 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 137756 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 3365 TREE CT. INDUSTRIAL BLVD. ST. LOUIS MO 63122 US |
| Baseline Brand Name | STORZ CIRCLING BAND (240 STYLE) |
| Baseline Generic Name | EXTRA OCULAR ORBITAL IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | E5381 700 |
| Baseline ID | NA |
| Baseline Device Family | RETINAL DETACHMENT IMPLANTS |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K832481 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-29 |