ARTHREX DX MATRIX 30031-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-09 for ARTHREX DX MATRIX 30031-02 manufactured by Dsm Biomedical.

Event Text Entries

[82150273] A design history review was conducted. The product met all acceptance criteria; packaging and sterilization were performed in accordance with pre-determined, validated parameters. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[82150274] It was reported approximately 2 weeks after implantation that the patient complained about "afflictions": fever (39. 6? ); shivers; wound was red with secretions; painful restriction of motion. Second arthroscopic surgery was necessary. Arthrex dx was removed; surgeon did a debridement and a lavage, and inserted a drain. A specimen was collected which did not show any microbiologic correlative germs. Three days later, surgeon did another lavage and inserted a new drain. Patient remained in the hospital for 12 days after the second surgery. The device was discarded by the facility because it was "putrid".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530154-2017-00004
MDR Report Key6776998
Report SourceDISTRIBUTOR,FOREIGN
Date Received2017-08-09
Date of Report2017-08-09
Date of Event2017-04-22
Date Mfgr Received2017-07-12
Device Manufacturer Date2017-02-13
Date Added to Maude2017-08-09
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. ALICE COUSENS
Manufacturer Street735 PENNSYLVANIA DRIVE
Manufacturer CityEXTON PA 19341
Manufacturer CountryUS
Manufacturer Postal19341
Manufacturer Phone4847132165
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTHREX DX MATRIX
Generic NameMESH, SURGICAL, COLLAGEN, PLASTIC AND RECONSTRUCTIVE SURGERY
Product CodeOXH
Date Received2017-08-09
Model Number30031-02
Lot NumberE0361
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDSM BIOMEDICAL
Manufacturer Address735 PENNSLYVANIA DRIVE EXTON PA 19341 US 19341


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-09

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