STORZ BARRAQUER EYE SPECULUM E4106S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 1996-11-01 for STORZ BARRAQUER EYE SPECULUM E4106S manufactured by Storz Instrument Co..

Event Text Entries

[32807] This eye speculum broke at the blade during a prk procedure. Another instrument was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1920664-1996-00098
MDR Report Key46845
Report Source00,06
Date Received1996-11-01
Date of Report1996-09-20
Date of Event1996-09-16
Date Facility Aware1996-09-16
Report Date1996-09-20
Date Reported to Mfgr1996-09-20
Date Mfgr Received1996-09-20
Date Added to Maude1996-11-07
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 Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTORZ BARRAQUER EYE SPECULUM
Generic NameEYE SPECULUM
Product CodeHNC
Date Received1996-11-01
Model NumberNA
Catalog NumberE4106S
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age3 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key47655
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address499 SOVEREIGN COURT ST LOUIS MO 63011 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-11-01

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