CORDCUTTER 214646

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-26 for CORDCUTTER 214646 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[139878658] Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter is an affiliate. Udi: (b)(4) - incomplete. The lot number is not currently available.
Patient Sequence No: 1, Text Type: N, H10


[139878659] It was reported by the affiliate that a part of the cutter broke off during assembling. This happened in the central sterile supply department and there was no patient or procedure involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-56693
MDR Report Key8452698
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-26
Date of Report2019-03-29
Date of Event2019-02-28
Date Mfgr Received2019-04-03
Date Added to Maude2019-03-26
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5089776860
Manufacturer G1DEPUY MITEK LLC US
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORDCUTTER
Generic NameSUTURE CUTTER
Product CodeFZT
Date Received2019-03-26
Returned To Mfg2019-03-29
Catalog Number214646
Lot Number17P03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-26

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