GAME READY AND KNEE WRAP, GAME READY / COOL SYSTEMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for GAME READY AND KNEE WRAP, GAME READY / COOL SYSTEMS manufactured by Coolsystems, Inc..

Event Text Entries

[144117029] Product did not state that it contained latex. Latex allergy. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086329
MDR Report Key8573584
Date Received2019-05-01
Date of Report2019-04-30
Date of Event2019-01-13
Date Added to Maude2019-05-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Details

Brand NameGAME READY AND KNEE WRAP, GAME READY / COOL SYSTEMS
Generic NamePACK, HOT OR COLD, WATER CIRCULATING
Product CodeILO
Date Received2019-05-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOLSYSTEMS, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-01

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