STORZ BOWMAN LACRIMAL PROBE E4201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-06 for STORZ BOWMAN LACRIMAL PROBE E4201 manufactured by Storz Instrument Co..

Event Text Entries

[133137] This instrument has a powder substance (fine residue) on it that is coming off on the pt's lacrimal punctum. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1998-00017
MDR Report Key161647
Report Source05,06
Date Received1998-04-06
Date of Report1998-03-09
Date of Event1998-03-07
Date Facility Aware1998-03-07
Report Date1998-03-09
Date Reported to Mfgr1998-03-09
Date Mfgr Received1998-03-09
Date Added to Maude1998-04-10
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 BOWMAN LACRIMAL PROBE
Generic NameLACRIMAL PROBE
Product CodeHNL
Date Received1998-04-06
Model NumberNA
Catalog NumberE4201
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key157390
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address499 SOVEREIGN CT. MANCHESTER MO 63011 US
Baseline Brand NameSTORZ BOWMAN LACRIMAL PROBE
Baseline Generic NameLACRIMAL PROBE
Baseline Model NoNA
Baseline Catalog NoE4201
Baseline IDNA
Baseline Device FamilyLACRIMAL PROBES
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1998-04-06

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