KRATZ-BARRAQUER EYE SPECULUM E4106 K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-04-02 for KRATZ-BARRAQUER EYE SPECULUM E4106 K manufactured by Storz Instrument Co..

Event Text Entries

[17764127] This eye speculum broke during an eye procedure. Another speculum was used. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1997-00034
MDR Report Key81314
Report Source06
Date Received1997-04-02
Date of Report1997-03-05
Date of Event1997-02-21
Date Facility Aware1997-02-21
Report Date1997-03-05
Date Reported to Mfgr1997-03-05
Date Mfgr Received1997-03-05
Date Added to Maude1997-04-08
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 NameKRATZ-BARRAQUER EYE SPECULUM
Generic NameEYE SPECULUM
Product CodeHNC
Date Received1997-04-02
Model NumberNA
Catalog NumberE4106 K
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key80750
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address3365 TREE CT. INDUSTRIAL BLVD. ST. LOUIS MO 63122 US
Baseline Brand NameKRATZ-BARRAQUER EYE SPECULUM
Baseline Generic NameOPHTHALMIC SPECULA
Baseline Model NoNA
Baseline Catalog NoE4106 K
Baseline IDNA
Baseline Device FamilyEYE SPECULA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1997-04-02

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