WITOUCH PRO 11.1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for WITOUCH PRO 11.1500 manufactured by Hollywog, Llc.

MAUDE Entry Details

Report Number3008585473-2019-00006
MDR Report Key8843245
Date Received2019-07-30
Date of Report2019-07-30
Date of Event2014-10-02
Date Mfgr Received2019-07-12
Date Added to Maude2019-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. MICHAEL TREAS
Manufacturer Street100 CHEROKEE BOULEVARD SUITE 123
Manufacturer CityCHATTANOOGA TN 37405
Manufacturer CountryUS
Manufacturer Postal37405
Manufacturer Phone4233057777
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWITOUCH PRO
Generic NameTRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR
Product CodeNUH
Date Received2019-07-30
Catalog Number11.1500
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLLYWOG, LLC
Manufacturer Address100 CHEROKEE BOULEVARD SUITE 123 CHATTANOOGA TN 37405 US 37405


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-07-30

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