MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-03-03 for SCLERAL BUCKLING IMPLANT manufactured by .
[165655]
"miragel scleral explant with swelling, diplopia and restriction of gaze".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-1999-00011 |
| MDR Report Key | 213068 |
| Report Source | 05 |
| Date Received | 1999-03-03 |
| Date of Report | 1999-03-03 |
| Date of Event | 1998-11-04 |
| Date Mfgr Received | 1999-03-02 |
| Device Manufacturer Date | 1988-11-01 |
| Date Added to Maude | 1999-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SCLERAL BUCKLING IMPLANT |
| Product Code | HQJ |
| Date Received | 1999-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 202737 |
| Baseline Brand Name | MIRAGEL |
| Baseline Generic Name | SCLERAL BUCKLING IMPLANT |
| Baseline Model No | 907 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SCLERAL BUCKLING COMPONENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K821793 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-03 |