MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-07 for MIRAGEL SCLERAL BUCKLE * manufactured by Mira, Inc..
[19160074]
A patient who had carried the diagnosis of turner syndrome since she was 10 suffered a retinal detachment 16 years ago, and despite surgical attempts of reattachment she developed no light perception due to recurrent detachment and proliferative vitreal retinopathy of the right eye. The buckle consisted of a miragel sponge that ultimately caused considerable discomfort for the globe. The patient had removal of the scleral buckle due to the pain and drainage from the "miragel. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 948929 |
| MDR Report Key | 948929 |
| Date Received | 2007-11-07 |
| Date of Report | 2007-11-07 |
| Date of Event | 2007-10-03 |
| Report Date | 2007-11-07 |
| Date Reported to FDA | 2007-11-07 |
| Date Added to Maude | 2007-11-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRAGEL SCLERAL BUCKLE |
| Generic Name | SCERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2007-11-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Age | 16 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 920524 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-07 |