CHATTANOOGA VECTA GENISYS COLD LASER THERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for CHATTANOOGA VECTA GENISYS COLD LASER THERAPY manufactured by Djo Global.

Event Text Entries

[74905852] I went for physical therapy, he/she treated me with cold laser therapy, after therapy i feel more pain and burning at spot of therapy, may be they hold it too long at one spot.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069640
MDR Report Key6553873
Date Received2017-05-05
Date of Report2017-05-05
Date of Event2017-05-02
Date Added to Maude2017-05-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCHATTANOOGA VECTA GENISYS COLD LASER THERAPY
Generic NameCHATTANOOGA VECTA GENISYS COLD LASER THERAPY
Product CodeILY
Date Received2017-05-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerDJO GLOBAL

Device Sequence Number: 1

Brand NameCHATTANOOGA VECTA GENISYS COLD LASER THERAPY
Generic NameCHATTANOOGA VECTA GENISYS COLD LASER THERAPY
Product CodeILY
Date Received2017-05-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHATTANOOGA GROUP


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-05

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