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 foreign report with the FDA on 2018-10-31 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.

Event Text Entries

[125647326] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[125647327] It was reported that after a traumatic injury, the patient was suffering from hand contraction. The idrt was applied fro tendon release. On day 21 post-application, medical staff removed the silicone layer followed by split thickness skin graft, and after 4 days of removal it was found that part of the wound was infected. The patient started antibiotic therapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1121308-2018-00097
MDR Report Key8023964
Report SourceFOREIGN
Date Received2018-10-31
Date of Report2018-10-17
Date Mfgr Received2019-01-10
Date Added to Maude2018-10-31
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 FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES CORPORATION
Manufacturer Street105 MORGAN LANE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal Code08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDRT, UNKNOWN
Generic NameINTEGRA
Product CodeMDD
Date Received2018-10-31
Catalog NumberXXX-IDRT
Lot Number3118767
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-31

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