D
Patient 1
PT HAD FIBROUS MASS THAT RESULTED IN IMMOBILITY. THE MASS OF FIBROUS MATERIAL WAS SURGICALLY REMOVED. THE MIRAGEL WAS PLACED 10 YEARS AGO.
MAUDE MDR 338885
- MDR report key
- 338885
- Report number
- 1218813-2001-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-05-13
- Date received
- 2001-06-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. STEVE TAMSETT
- Address
- 414 QUAKER HIGHWAY UXBRIDGE MA 01569 US
- Phone
- 508-508-5082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MIRAGEL | SCLERAL BUCKLING DEVICE | MIRA, INC. | HQJ | NA | NA | NA | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-06-01 | 0 | 1. R |