IDRT SINGLE LAYER (INTL) 2X2 SINGLE 62021

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 2018-05-18 for IDRT SINGLE LAYER (INTL) 2X2 SINGLE 62021 manufactured by Integra Lifesciences Corporation.

Event Text Entries

[108654108] 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


[108654109] It was reported two patients with delayed seroma under the integra idrt, both elderly trauma female patients. Surgeon is suturing the idrt and patients are non-weight bearing for the first week. First case: wound in the ankle, caused by trauma. Idrt was used. On week 3 a collection of fluid under the graft was noticed and gradual graft loss. One (1) of two (2) reports - other mfg report number: 1121308-2018-00025.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1121308-2018-00024
MDR Report Key7525472
Report SourceFOREIGN
Date Received2018-05-18
Date of Report2018-05-01
Date Mfgr Received2018-06-01
Date Added to Maude2018-05-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTAL HYGIENIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SONIA IRIZARRY
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 SINGLE LAYER (INTL) 2X2 SINGLE
Generic NameIDRT
Product CodeMDD
Date Received2018-05-18
Catalog Number62021
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-18

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