BIONICARE KNEE DEVICE B1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-13 for BIONICARE KNEE DEVICE B1000 manufactured by Bionicare Medical Technologies, Inc..

Event Text Entries

[15218957] The patient developed a rash on the knee after using the device for approximately three weeks. The rash continued to spread down the side of the pt's leg.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5004391
MDR Report Key947943
Date Received2007-11-13
Date of Report2007-11-12
Date of Event2007-10-04
Date Added to Maude2007-11-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBIONICARE KNEE DEVICE
Generic NameBIONICARE KNEE DEVICE
Product CodeNYN
Date Received2007-11-13
Model NumberB1000
ID NumberKLS000001517
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key921481
ManufacturerBIONICARE MEDICAL TECHNOLOGIES, INC.
Manufacturer AddressSPARKS MD 21152 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-11-13

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