MEDTRONIC SOFSILK 0, V-20 SUTURE CVNGS834

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for MEDTRONIC SOFSILK 0, V-20 SUTURE CVNGS834 manufactured by Medtronic / Covidien.

Event Text Entries

[182385959] Physician was closing skin with sofsilk 0, v-20 suture. The needle tip broke while suturing. The tip of the needle was located. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093520
MDR Report Key9792902
Date Received2020-03-04
Date of Report2020-03-02
Date of Event2020-02-05
Date Added to Maude2020-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC SOFSILK 0, V-20 SUTURE
Generic NameSUTURE, NON ABSORBABLE, SILK
Product CodeGAP
Date Received2020-03-04
Model NumberCVNGS834
Lot NumberD860951X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC / COVIDIEN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-04

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