GENTLE TOUCH 1937

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-31 for GENTLE TOUCH 1937 manufactured by Mizuho Orthopedic Systems, Inc..

Event Text Entries

[146698652] It was reported that the patient had pressure sore to left side of chin following procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2921578-2019-00021
MDR Report Key8659827
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-05-31
Date of Report2019-07-15
Date of Event2019-04-17
Date Mfgr Received2019-06-21
Date Added to Maude2019-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location3
Manufacturer ContactANNE LEBLANC
Manufacturer Street30031 AHERN AVENUE
Manufacturer CityUNION CITY CA 945871234
Manufacturer CountryUS
Manufacturer Postal945871234
Manufacturer Phone5104291500
Manufacturer G1MIZUHO ORTHOPEDIC SYSTEMS, INC.
Manufacturer Street30031 AHERN AVENUE
Manufacturer CityUNION CITY CA 945871234
Manufacturer CountryUS
Manufacturer Postal Code945871234
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENTLE TOUCH
Generic NameHEADREST PILLOW
Product CodeCCX
Date Received2019-05-31
Model Number1937
Catalog Number1937
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIZUHO ORTHOPEDIC SYSTEMS, INC.
Manufacturer Address30031 AHERN AVENUE UNION CITY CA 945871234 US 945871234


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-31

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