UMBILI-CLAMP CLW-1005-A01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for UMBILI-CLAMP CLW-1005-A01 manufactured by Divergent Medical Technologies, Inc..

Event Text Entries

[68997877]
Patient Sequence No: 1, Text Type: N, H10


[68997878] Patient presented to mb with umbilical cord actively bleeding. Appeared as if the tot guard was causing the umbilical cord to "shred" causing the bleeding.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6375967
MDR Report Key6375967
Date Received2017-03-03
Date of Report2017-02-14
Date of Event2017-02-05
Report Date2017-02-14
Date Reported to FDA2017-02-14
Date Reported to Mfgr2017-02-14
Date Added to Maude2017-03-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 NameUMBILI-CLAMP
Generic NameDEVICE, OCCLUSION, UMBILICAL
Product CodeFOD
Date Received2017-03-03
Model NumberCLW-1005-A01
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDIVERGENT MEDICAL TECHNOLOGIES, INC.
Manufacturer Address5 FIR CT STE 1A OAKLAND NJ 07436 US 07436


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-03

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