JARIT * 360-273

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-01 for JARIT * 360-273 manufactured by Integra York Pa, Inc.

Event Text Entries

[17951484] Lacrimal duct probe number broke off in scrub's hand. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3095491
MDR Report Key3095491
Date Received2013-05-01
Date of Report2013-05-01
Date of Event2013-04-26
Report Date2013-05-01
Date Reported to FDA2013-05-01
Date Reported to Mfgr2013-05-07
Date Added to Maude2013-05-07
Event Key0
Report Source CodeUser Facility 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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameJARIT
Generic NameLACRIMAL DUCT PROBE
Product CodeHNL
Date Received2013-05-01
Model Number*
Catalog Number360-273
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK PA, INC
Manufacturer Address589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-01

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