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 literature report with the FDA on 2018-01-31 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.

Event Text Entries

[98698340] Three of 3 reports - other mfg report numbers: 1121308-2018-00005 and 1121308-2018-00006. Investigation completed on 26jan2018. It is difficult to pinpoint the exact root cause of the infection. The failure is unconfirmed, as there was no product returned for this complaint. No product lot number is provided so a dhr review could not be conducted. All product is released based on passing of all in process and finished goods criteria. This includes ensuring that sterile product gets to the customer. Based on the risk documentation review, the most probable root cause can be that the environment post application was inadequate for wound healing.
Patient Sequence No: 1, Text Type: N, H10


[98698341] Three of 3 reports: the plastic and reconstructive surgery journal (2017) publish:? A retrospective look at integrating a novel regenerative medicine approach in plastic limb reconstruction? . The purpose of this retrospective study was to evaluate the effectiveness of an innovative approach whereby several therapies were combined to avoid amputation. Seventeen patients with full-thickness wounds who were previously recommended for amputation and were treated with the combinatorial approach of muscle flap reconstruction and concentrated bone marrow aspirate, platelet-rich plasma, integra wound matrix, vacuum-assisted closure, and split-thickness skin grafts were assessed retrospectively. Three of the 17 patients had superficial infections in the postoperative course; treated with systemic antibiotics for 6 weeks. These patients where diagnosed with active osteomyelitis before the procedure; however, the superficial infection was considered a postoperative complication.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1121308-2018-00007
MDR Report Key7231586
Report SourceLITERATURE
Date Received2018-01-31
Date of Report2018-01-08
Date Mfgr Received2018-01-08
Date Added to Maude2018-01-31
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 ContactMRS. 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 CodeKGN
Date Received2018-01-31
Catalog NumberXXX-IDRT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-01-31

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