SONIC COMFORT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for SONIC COMFORT manufactured by Innovate, Llc.

Event Text Entries

[40059789] Husband suffered skin burns on his back. Home/apartment/condominium - (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060792
MDR Report Key5489896
Date Received2016-03-07
Date of Report2016-02-25
Date of Event2016-02-25
Date Added to Maude2016-03-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 NameSONIC COMFORT
Generic NamePERSONAL MASSAGER WITH HEAT THERAPY
Product CodeISA
Date Received2016-03-07
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerINNOVATE, LLC
Manufacturer AddressPLANO TX 75024 US 75024


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.