FDA Adverse Event
Injury
Summary report: N
MIRAGEL
MDR report key: 175440
·
Received July 2, 1998
Report
- Report Number
- 1218813-1998-00006
- Event Type
- Injury
- Date Received
- July 2, 1998
- Date of Event
- December 16, 1996
- Report Date
- June 24, 1998
- Manufacturer
- MIRA INC
- Product Code
- HQJ
- Removal / Correction Number
- 1013940
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
EXTRUDING SCLERAL BUCKLE (MIRAGEL)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGEL Implant | SCLERAL BUCKLING COMPONENT | HQJ | MIRA INC | 906 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |