BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRPRO 2.1 AND KNEE WRAP

    MDR report key: 8661094 · Received May 31, 2019

    Report

    Report Number
    2954777-2019-00001
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    January 13, 2019
    Report Date
    May 31, 2019
    Manufacturer
    COOLSYSTEMS, INC. (DBA GAME READY)
    Product Code
    ILO
    PMA / PMN Number
    K072620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NOTIFICATION OF THE REPORTED EVENT WAS RECEIVED BY COOLSYSTEMS, INC. ON MAY 13, 2019 VIA UNITED STATES POSTAL SERVICE LETTER SENT BY FDA. THE LETTER INFORMED COOLSYSTEMS, INC. OF THE PATIENT-REPORTED ADVERSE EVENT, WHICH WAS SUBMITTED THROUGH THE FDA MEDWATCH PROGRAM (REF. MW5086329). COOLSYSTEMS, INC. HAS COMPLETED A QUERY OF ITS INTERNAL CUSTOMER DATABASE TO RETRIEVE PATIENT CONTACT INFORMATION BASED ON THE INITIAL REPORTER NAME DISCLOSED IN THE MEDWATCH (MW) REPORT. THIS SEARCH IDENTIFIED NO MATCHING RESULTS. AS NO INITIAL REPORTER CONTACT INFORMATION WAS PROVIDED WITH THE MW, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED REGARDING THE ALLEGED INCIDENT. BASED ON THE LIMITED DEVICE DESCRIPTION INCLUDED IN THE MW (GAME READY GRPRO 2.1 AND KNEE WRAP) AND LACK OF CONTACT INFORMATION, THE TYPE/MODEL OR LOT NUMBER OF KNEE WRAP REFERENCED IN THE REPORTED EVENT COULD NOT BE IDENTIFIED OR CONFIRMED. TWO DESIGNS OF KNEE WRAP ARE DISTRIBUTED; STRAIGHT AND ARTICULATED. THE STRAIGHT KNEE WRAP IS NOT MANUFACTURED WITH NATURAL RUBBER LATEX. THE ARTICULATED KNEE WRAP MAY INCLUDE LATEX STRANDS THAT ARE ENCLOSED WITHIN NYLON OR POLYESTER FIBERS AND LOCATED IN ONLY THE OUTER SECURING STRAP OF THE WRAP. THESE LATEX STRANDS DO NOT CONTACT THE USER/PATIENT, AND THERE HAVE BEEN NO PRIOR REPORTS RECEIVED INDICATING OCCURRENCE OF A LATEX ALLERGY. INVESTIGATION TO IDENTIFY CONTACT INFORMATION OF THE INITIAL REPORTER TO OBTAIN ADDITIONAL EVENT DETAILS IS ONGOING.

    Description of Event or Problem · 1

    ON MAY 13, 2019, COOLSYSTEMS, INC. RECEIVED A LETTER FROM THE FDA WITH MEDWATCH REPORT #5086329 AS AN ATTACHMENT. IN THIS REPORT THE EVENT DESCRIPTION READS "PRODUCT DID NOT STATE THAT IT CONTAINED LATEX. LATEX ALLERGY. FDA SAFETY REPORT ID# (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453285 GRPRO 2.1 AND KNEE WRAP COLD- AND INTERMITTENT COMPRESSION ILO COOLSYSTEMS, INC. (DBA GAME READY)

    Patients

    Seq Age Sex Outcome Treatment
    1