NTI TENSION SUPPRESSION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for NTI TENSION SUPPRESSION SYSTEM manufactured by Therapeutic Solutions International.

Event Text Entries

[38413514] Patient received an "nti" splint and ow her teeth are shifting and moving everywhere. Additionally, it did not help with pain and made it worse.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060227
MDR Report Key5442019
Date Received2016-02-11
Date of Report2016-02-11
Date of Event2016-02-11
Date Added to Maude2016-02-17
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 NameNTI TENSION SUPPRESSION SYSTEM
Generic NameNTI TENSION SUPPRESSION SYSTEM
Product CodeLQZ
Date Received2016-02-11
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTHERAPEUTIC SOLUTIONS INTERNATIONAL


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-02-11

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