ETHMCM30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for ETHMCM30 manufactured by Sterilmed, Inc..

Event Text Entries

[146218090] The reprocessed ligaclip failed. The physician tried to control bleeding with clip applier. The reprocessed clip applier was not functioning correctly and a brand new clip applier was opened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8645209
MDR Report Key8645209
Date Received2019-05-28
Date of Report2019-05-15
Date of Event2019-05-14
Report Date2019-05-15
Date Reported to FDA2019-05-15
Date Reported to Mfgr2019-05-28
Date Added to Maude2019-05-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameCLIP, IMPLANTABLE, REPROCESSED
Product CodeNMJ
Date Received2019-05-28
Model NumberETHMCM30
Catalog NumberETHMCM30
Lot Number2058827
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer Address5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-28

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