STORZ BARRAQUER EYE SPECULUM E4106 S

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 1998-05-08 for STORZ BARRAQUER EYE SPECULUM E4106 S manufactured by Bausch & Lomb Surgical.

Event Text Entries

[19236157] This speculum broke during a procedure. There was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1998-00028
MDR Report Key167316
Report Source06
Date Received1998-05-08
Date of Report1998-04-09
Date of Event1998-04-09
Date Facility Aware1998-04-09
Report Date1998-04-09
Date Mfgr Received1998-04-09
Date Added to Maude1998-05-14
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 Received1998-05-08
Model NumberNA
Catalog NumberE4106 S
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key162815
ManufacturerBAUSCH & LOMB SURGICAL
Manufacturer Address499 SOVEREIGN CT. ST LOUIS MO 63011 US
Baseline Brand NameSTORZ BARRAQUER EYE SPECULUM
Baseline Generic NameOPHTHALMIC SPECULA
Baseline Model NoNA
Baseline Catalog NoE4106 S
Baseline IDNA
Baseline Device FamilyEYE SPECULUM
Baseline Shelf Life ContainedA
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1998-05-08

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