TWM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-21 for TWM manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[180519356] Per complaint (b)(4), a customer received a torque wrench with incorrect instructions for use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2020-00582
MDR Report Key9742519
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-21
Date of Report2020-02-21
Date of Event2020-01-23
Date Mfgr Received2020-01-23
Device Manufacturer Date2019-06-10
Date Added to Maude2020-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ADRIENNE STOTT
Manufacturer Street3050 EAST HILLCREST DRIVE
Manufacturer CityTHOUSAND OAKS, CA
Manufacturer CountryUS
Manufacturer Phone4443300357
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTWM
Generic NameTORQUE WRENCH
Product CodeNDP
Date Received2020-02-21
Returned To Mfg2020-01-30
Model NumberTWM
Catalog NumberTWM
Lot Number143685
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerIMPLANT DIRECT SYBRON MANUFACTURING LLC
Manufacturer Address3050 EAST HILLCREST DRIVE THOUSAND OAKS, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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