MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-01 for MIRAGEL manufactured by Mira, Inc..
[222059]
Pt had fibrous mass that resulted in immobility. The mass of fibrous material was surgically removed. The miragel was placed 10 years ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2001-00003 |
| MDR Report Key | 338885 |
| Date Received | 2001-06-01 |
| Date of Report | 2001-05-31 |
| Date of Event | 2001-05-13 |
| Date Mfgr Received | 2001-05-14 |
| Date Added to Maude | 2001-06-27 |
| 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 DEVICE |
| Product Code | HQJ |
| Date Received | 2001-06-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 328189 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | 414 QUAKER HWY UXBRIDGE MA 01569 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-06-01 |