INTEGRA JARIT 505-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for INTEGRA JARIT 505-200 manufactured by Integra Lifesciences Corporation.

MAUDE Entry Details

Report Number9191021
MDR Report Key9191021
Date Received2019-10-15
Date of Report2019-09-25
Date of Event2019-09-09
Report Date2019-09-26
Date Reported to FDA2019-09-26
Date Reported to Mfgr2019-10-10
Date Added to Maude2019-10-15
Event Key0
Report Source CodeUser Facility 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 Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTEGRA JARIT
Generic NameTENACULUM, UTERINE
Product CodeHDC
Date Received2019-10-15
Model Number505-200
Catalog Number505-200
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address311 ENTERPRISE DR PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-15

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