HYDROLLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for HYDROLLATOR manufactured by Unknown.

MAUDE Entry Details

Report NumberMW5089054
MDR Report Key8894692
Date Received2019-08-13
Date of Report2019-08-12
Date of Event2019-07-24
Date Added to Maude2019-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameHYDROLLATOR
Generic NameUNIT, HEATING, POWERED
Product CodeIRQ
Date Received2019-08-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN

Device Sequence Number: 2

Brand NameHEATPAC
Generic NamePACK, HEAT, MOIST
Product CodeIMA
Date Received2019-08-13
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-08-13

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