IDRT-TS (INTL) SINGLE 4X5 84051

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 2012-10-19 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corp..

Event Text Entries

[3085579] The reporter noted the pt was enrolled in a clinical study in (b)(6) titled: "eval of integra artificial dermis for the treatment of leg ulcers. The pt underwent implantation of idrt on (b)(6) 2011, on a mixed ulcer. The pt developed a local infection on (b)(6) 2011, under the silicone (positive for pseudomonas "aerugosima" and e coli). Antibiotic treatment and washing were provided. The infection subsided on (b)(6) 2011. The pt developed a new infection on (b)(6) 2011, with lysis of the graft at 80%. Treatment was provided with a different dressing.
Patient Sequence No: 1, Text Type: D, B5


[10435802] 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 Number1121308-2012-00032
MDR Report Key2802358
Report Source01,02,05,07
Date Received2012-10-19
Date of Report2012-10-19
Date Mfgr Received2012-09-27
Date Added to Maude2012-10-25
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 FERNANDEZ
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-TS (INTL) SINGLE 4X5
Generic NameIDRT-TS
Product CodeMGR
Date Received2012-10-19
Catalog Number84051
Lot Number105C00207932
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. Required No Informationntervention 2012-10-19

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