IDRT, UNKNOWN XXX-IDRT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-09 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..

Event Text Entries

[4135280] This is the third report of three from the same facility, the same surgeon same product; same issue but different pt. There was no pt info reported. It was reported that a piece of 5cms x 5cms idrt bilayer was badly kinked. (this was the third of three times this has happened in the past few weeks).
Patient Sequence No: 1, Text Type: D, B5


[11513293] The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2013-00059
MDR Report Key3624317
Report Source01,05,07
Date Received2013-12-09
Date of Report2013-12-09
Date Mfgr Received2013-11-13
Date Added to Maude2014-04-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCAREN FINKELSTEIN
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDRT, UNKNOWN
Generic NameINTEGRA
Product CodeMDD
Date Received2013-12-09
Catalog NumberXXX-IDRT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP.
Manufacturer AddressPLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-09

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