MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-09 for MIRAGEL UNK manufactured by Mira, Inc..
[207677]
Miragel was episclerally removed by the dr. There were four patients in the past two months. The age of the device is approximately ten years old. There was no injury to the eye, the fourth patient experienced some degree of discomfort, however, the dr stated miragel was not the cause for this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2001-00001 |
| MDR Report Key | 332486 |
| Report Source | 05 |
| Date Received | 2001-05-09 |
| Date of Report | 2001-04-30 |
| Date of Event | 2001-04-19 |
| Date Mfgr Received | 2001-04-19 |
| Date Added to Maude | 2001-05-16 |
| 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 | 0 |
| Manufacturer Contact | MR. STEVE TAMSETT |
| Manufacturer Street | 414 QUAKER HIGHWAY |
| Manufacturer City | UXBRIDGE MA 01569 |
| Manufacturer Country | US |
| Manufacturer Postal | 01569 |
| Manufacturer Phone | 5082787877 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRAGEL |
| Generic Name | SCLERAL BUCKLING COMPONENT |
| Product Code | HQJ |
| Date Received | 2001-05-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 321849 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-05-09 |