STORZ KELLY DECEMET MEMBRANE PUNCH E2798

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 1997-01-03 for STORZ KELLY DECEMET MEMBRANE PUNCH E2798 manufactured by Storz Instrument Co..

Event Text Entries

[15039465] During an ophthalmic procedure, pieces of the coating of this instrument fell off into the eye. The pieces were able to be aspirated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1997-00001
MDR Report Key73390
Report Source05,06
Date Received1997-01-03
Date of Report1996-12-03
Date of Event1996-08-22
Date Facility Aware1996-08-22
Report Date1996-12-03
Date Reported to Mfgr1996-12-03
Date Mfgr Received1996-12-03
Date Added to Maude1997-03-07
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 KELLY DECEMET MEMBRANE PUNCH
Generic NameOPHTHALMIC MEMBRANE PUNCH
Product CodeHNJ
Date Received1997-01-03
Model NumberNA
Catalog NumberE2798
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age9 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key73220
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address499 SOVEREIGN CT ST LOUIS MO 63011 US
Baseline Brand NameKELLY DECEMET MEMBRANE PUNCH
Baseline Generic NameCORNEO-SCLERAL PUNCH
Baseline Model NoNA
Baseline Catalog NoE2798
Baseline ID*
Baseline Device FamilyOPHTHALMIC PUNCH
Baseline Shelf Life ContainedA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
10 1997-01-03

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