MIRAGEL 904 SAME

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1218813-1998-00010
MDR Report Key188958
Report Source01,08
Date Received1998-09-22
Date of Report1998-09-14
Date of Event1998-01-01
Date Mfgr Received1998-09-12
Date Added to Maude1998-09-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameMIRAGEL
Generic NameSCLERAL BUCKLING COMPONENT
Product CodeHQJ
Date Received1998-09-22
Model Number904
Catalog NumberSAME
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedY
Device Sequence No1
Device Event Key183626
ManufacturerMIRA INC.
Manufacturer Address87 RUMFORD AVE. WALTHAM MA 02454 US
Baseline Brand NameMIRAGEL
Baseline Generic NameSCLERAL BUCKLING IMPLANT
Baseline Model No904
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilySCLERAL BUCKLING COMPONENTS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK821793
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1998-09-22

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