IDRT SINGLE LAYER (INTL) 2X2 5 PACK 62025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2014-07-24 for IDRT SINGLE LAYER (INTL) 2X2 5 PACK 62025 manufactured by Integra Lifesciences Corp..

Event Text Entries

[4774981] It was reported during a study conducted in (b)(6), titled: (b)(4), implantation of the idrt sl in one step to the pt's leg on (b)(6) 2014. On (b)(6) 2014, accumulation of fluid was observed and detachment from the wound. The graft failed. The pt refused a new graft. Closure of the wound on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5


[12303301] This product is not approved for sale in the united states and this study investigated a technique not included in the united states. The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2014-00025
MDR Report Key4004704
Report Source01,02,05,07
Date Received2014-07-24
Date of Report2014-07-02
Date of Event2014-03-04
Date Mfgr Received2014-07-02
Date Added to Maude2014-08-14
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 DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDRT SINGLE LAYER (INTL) 2X2 5 PACK
Generic NameIDRT
Product CodeMDD
Date Received2014-07-24
Catalog Number62025
Lot Number105B00254166
Device Expiration Date2014-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP.
Manufacturer AddressPLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-07-24

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