MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-09-22 for MIRAGEL 904 SAME manufactured by Mira Inc..
[99742]
Complications from miragel sponge; pt claims a feel of foreign material in eye. Re-implanted and pt now is recovered. Original implantation was six to eight years ago.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1218813-1998-00010 |
MDR Report Key | 188958 |
Report Source | 01,08 |
Date Received | 1998-09-22 |
Date of Report | 1998-09-14 |
Date of Event | 1998-01-01 |
Date Mfgr Received | 1998-09-12 |
Date Added to Maude | 1998-09-28 |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MIRAGEL |
Generic Name | SCLERAL BUCKLING COMPONENT |
Product Code | HQJ |
Date Received | 1998-09-22 |
Model Number | 904 |
Catalog Number | SAME |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | Y |
Date Removed | Y |
Device Sequence No | 1 |
Device Event Key | 183626 |
Manufacturer | MIRA INC. |
Manufacturer Address | 87 RUMFORD AVE. WALTHAM MA 02454 US |
Baseline Brand Name | MIRAGEL |
Baseline Generic Name | SCLERAL BUCKLING IMPLANT |
Baseline Model No | 904 |
Baseline Catalog No | NA |
Baseline ID | NA |
Baseline Device Family | SCLERAL BUCKLING COMPONENTS |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K821793 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1998-09-22 |