907 SAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-03-03 for 907 SAME manufactured by .

Event Text Entries

[165652] Extrusion scleral buckle, right eye".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1218813-1999-00004
MDR Report Key213049
Report Source05
Date Received1999-03-03
Date of Report1999-03-03
Date of Event1998-12-09
Date Mfgr Received1999-03-02
Date Added to Maude1999-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Generic NameSCLERAL BUCKLING IMPLANT
Product CodeHQJ
Date Received1999-03-03
Model Number907
Catalog NumberSAME
ID NumberNA
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedB
Device Sequence No1
Device Event Key202757
Baseline Brand NameMIRAGEL
Baseline Generic NameSCLERAL BUCKLING IMPLANT
Baseline Model No907
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
10 1999-03-03

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