MEDICHOICE HTP020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for MEDICHOICE HTP020 manufactured by Owens & Minor Distribution, Inc..

MAUDE Entry Details

Report Number8868786
MDR Report Key8868786
Date Received2019-08-07
Date of Report2019-07-31
Date of Event2019-06-12
Report Date2019-07-31
Date Reported to FDA2019-07-31
Date Reported to Mfgr2019-08-07
Date Added to Maude2019-08-07
Event Key0
Report Source CodeUser Facility 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 Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDICHOICE
Generic NamePACK, HOT OR COLD, WATER CIRCULATING
Product CodeILO
Date Received2019-08-07
Returned To Mfg2019-06-14
Model NumberHTP020
Lot NumberA1300119D
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOWENS & MINOR DISTRIBUTION, INC.
Manufacturer Address9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-07

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