NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-06-13 for NONE manufactured by Integra Lifesciences Corp..

Event Text Entries

[3516562] This is the second of three reports regarding idrt (product id not provided). It was reported that the customer is doing a retrospective study of idrt and reported 3 cases of allergy with idrt since 1995 in his hospital. The patients were third degree burned, they had several grafts of idrt, and had delay in cicatrization with some reactions like eczema in the grafted area. Product will not be returned. Additional information has been requested; however, when the sales representative met with the doctor, he only managed to see the patient file on one patient and not for the patient in this report.
Patient Sequence No: 1, Text Type: D, B5


[10851389] The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2013-00024
MDR Report Key3179578
Report Source01
Date Received2013-06-13
Date of Report2013-06-13
Date Mfgr Received2013-05-29
Date Added to Maude2013-06-21
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 ContactROWENA SALVADOR
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameNONE
Product CodeMDD
Date Received2013-06-13
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
101. Other 2013-06-13

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