EXETER CUP INTRODUCER 0930-3-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-01-24 for EXETER CUP INTRODUCER 0930-3-000 manufactured by Howmedica Inc..

Event Text Entries

[43206] The locking mechanism connecting handle and distal part is broken. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010096-1997-00003
MDR Report Key65397
Report Source01,07
Date Received1997-01-24
Date of Report1997-01-24
Report Date1997-01-23
Date Mfgr Received1996-12-20
Date Added to Maude1997-01-30
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
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameEXETER CUP INTRODUCER
Generic NameINSTRUMENT
Product CodeKIL
Date Received1997-01-24
Model NumberNA
Catalog Number0930-3-000
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key65491
ManufacturerHOWMEDICA INC.
Manufacturer Address359 VETERANS BLVD RUTHERFORD NJ 07070 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-01-24

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