MEDTRONIC 3-0 MONOSOF P-14 SUTURE SN-5663

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for MEDTRONIC 3-0 MONOSOF P-14 SUTURE SN-5663 manufactured by Medtronic / Covidien.

Event Text Entries

[183118455] Suture [invalid] broke - sent back with rep. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093630
MDR Report Key9810776
Date Received2020-03-09
Date of Report2020-03-06
Date of Event2020-03-05
Date Added to Maude2020-03-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 3-0 MONOSOF P-14 SUTURE
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC POLYAMIDE
Product CodeGAR
Date Received2020-03-09
Model NumberSN-5663
Catalog NumberSN-5663
Lot NumberD9HO63OFY
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC / COVIDIEN
Manufacturer AddressMINNEAPOLIS MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.