LIDO 820294-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-18 for LIDO 820294-01 manufactured by Loredam Biomedical, Inc..

Event Text Entries

[16368] Pt was doing isokinetic workout. Washer was broken. And machine twisted due to torque, which caused valgus stress on the joint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number30535
MDR Report Key30535
Date Received1996-01-18
Date of Report1995-12-01
Date of Event1995-10-09
Date Facility Aware1995-10-18
Report Date1996-01-09
Date Added to Maude1996-03-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIDO
Generic NameLIDO
Product CodeIKK
Date Received1996-01-18
Model Number820294-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key31598
ManufacturerLOREDAM BIOMEDICAL, INC.
Manufacturer Address3650 INDUSTRIAL BLVD WEST SACRAMENTO CA 95691 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-01-18

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