ENSEKIGAISEN ONNETSUKI ("ONNETSU") M1-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-02-14 for ENSEKIGAISEN ONNETSUKI ("ONNETSU") M1-01 manufactured by Mitsui Onnetsu Co..

Event Text Entries

[17396944] In a lawsuit, the estate of (b)(6) alleges that his death was caused by an infection caused by a burn caused by his home health care aide's personal use (it was not part of his prescribed care) of the onnetsu device while massaging him on his remaining leg (his other had been amputated due to diabetes). The aide has testified that she did not use the device on his leg and that wherever she used it on his body, she used it properly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004057530-2011-00001
MDR Report Key1988256
Report Source99
Date Received2011-02-14
Date of Report2009-04-29
Date of Event2007-05-28
Date Facility Aware2009-06-01
Report Date2011-02-04
Date Added to Maude2011-11-02
Event Key0
Report Source CodeDistributor 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 Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENSEKIGAISEN ONNETSUKI ("ONNETSU")
Generic NameINFRARED THERAPEUTIC HANDHELD MASSAGER
Product CodeISA
Date Received2011-02-14
Model NumberM1-01
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMITSUI ONNETSU CO.
Manufacturer AddressMURAMATSU BID 4F 2-2-10 SHINBASHI HIGASHI MINATOKU-TOKYO JA


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2011-02-14

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