RULER 71674079

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-21 for RULER 71674079 manufactured by Smith & Nephew, Inc..

Event Text Entries

[133738608] .
Patient Sequence No: 1, Text Type: N, H10


[133738609] It was reported that the threads on ruler broke during surgery. No delay or patient injury reported. A backup device was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2019-00218
MDR Report Key8264527
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-21
Date of Report2019-02-21
Date of Event2018-12-24
Date Mfgr Received2018-12-24
Date Added to Maude2019-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR SARAH FREESTONE
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRULER
Generic NameTAPE, MEASURING, RULERS AND CALIPERS
Product CodeFTY
Date Received2019-01-21
Returned To Mfg2019-01-03
Catalog Number71674079
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-21

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