ETHICON SUTURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-06 for ETHICON SUTURE manufactured by Ethicon.

Event Text Entries

[697040] In 2007, needle tip noted to be missing after suturing pt. Unable to find tip. Ethicon monocryl 1. Route: cutaneous, dates of use: two months in 2007. Diagnosis or reason for use: surgical suture material, event abated after use stopped or dose reduced? Yes. Event reappeared after reintroduction? No.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5003681
MDR Report Key910360
Date Received2007-09-06
Date of Report2007-09-06
Date Added to Maude2007-09-20
Event Key0
Report Source CodeVoluntary 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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameETHICON SUTURE
Generic NameETHICON SUTURE
Product CodeHAS
Date Received2007-09-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key887850
ManufacturerETHICON


Patients

Patient NumberTreatmentOutcomeDate
10 2007-09-06

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