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

[21384970] In 2007, needle tip noted to be missing afgter suturing pt. Unable to find tip. No packaging. Dates of use: approx 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 NumberMW5003682
MDR Report Key910361
Date Received2007-09-06
Date of Report2007-09-06
Date Added to Maude2007-09-19
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 FDA3
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
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key887808
ManufacturerETHICON
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2007-09-06

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