IDRT-TS (INTL) SINGLE 2X2 82021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-02-27 for IDRT-TS (INTL) SINGLE 2X2 82021 manufactured by Integra Lifesciences Corp.

Event Text Entries

[15205992] This is the second report of two concerning the same product with the same reported issue. (see mfg report number 1121308-2014-00007). This report concerns the second idrt. It was reported "during a surgery when the first idrt was opened, polyethylene sheets were found to have been shifted slightly and formed wrinkles on idrt. The product was not used for the surgery. A second idrt was opened with the same issue. A third idrt was opened and applied to a pt to finish the surgery.
Patient Sequence No: 1, Text Type: D, B5


[15788445] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2014-00008
MDR Report Key3727545
Report Source01,08
Date Received2014-02-27
Date of Report2014-02-12
Date Mfgr Received2014-02-12
Date Added to Maude2014-05-12
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 8536
Manufacturer CountryUS
Manufacturer Postal8536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDRT-TS (INTL) SINGLE 2X2
Generic NameIDRT-TS
Product CodeMGR
Date Received2014-02-27
Catalog Number82021
Lot Number105NA0277860
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP
Manufacturer AddressPLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-27

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