BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAME READY ACCELERATED RECOVERY SYSTEM

    MDR report key: 813643 · Received January 29, 2007

    Report

    Report Number
    2954777-2007-00001
    Event Type
    Other
    Date Received
    January 29, 2007
    Date of Event
    December 20, 2006
    Manufacturer
    COOLSYSTEMS, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. INCLUDED WITH REPORT: CONTROL UNIT QUICK START CARD. PRINT OUT OF CONTROL UNIT USER'S MANUAL. PRINT OUT OF CONTROL UNIT QUICK START GUIDE. PRINT OUT OF LEFT SHOULDER USE GUIDE. SPEC: CONTROL UNIT S/N LABEL. SPEC: CONTROL UNIT ELEC. SAFETY LABEL. SPEC: LEFT SHOULDER SLEEVE LABEL. SPEC: LEFT SHOULDER SLEEVE CARE LABEL. SPEC: LEFT SHOULDER ID LABEL. ART: LEFT SHOULDER HEAT EXCHANGER PKG LABEL. SPEC: LEFT SHOULDER HEAT EXCHANGER LABEL.

    Description of Event or Problem · 1

    IT IS BELIEVED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON HIS LEFT SHOULDER, AND THAT THE GAME READY ACCELERATED RECOVERY SYSTEM WAS PRESCRIBED FOR USE POST-OPERATIVELY, DURING THE FOLLOWING 14 DAYS AT APPROX 40 DEGREES F IN 30 MINUTE INTERVALS, ALTERNATING BETWEEN NO TREATMENT AND THE APPLICATION OF THE GAME READY SHOULDER WRAP FOR "SEVERAL HOURS DAILY." THE PATIENT WAS SEEN BY HIS PHYSICIAN FOR FOLLOW-UP ON OR AROUND DAY 14. DURING THE FOLLOW-UP VISIT, THE PATIENT'S PHYSICIAN NOTED WHAT APPEARED TO BE "SOME FROSTBITE" ON THE TREATED AREA. IT IS UNKNOWN WHETHER THE EVENT REQUIRED INTERVENTION TO PREVENT IMPAIRMENT / DAMAGE, OR IF A SUBSEQUENT DIAGNOSIS WAS MADE. THE PATIENT REPORTED THE EVENT TO A THIRD-PARTY COOLSYSTEMS DISTRIBUTOR REPRESENTATIVE ON 12/29/06, WHO IN TURN REPORTED THE DETAILS ABOVE TO COOLSYSTEMS ON 01/02/07. FIVE ATTEMPTS VIA TELEPHONE AND EMAIL BETWEEN 01/03/07 AND 1/26/07 HAVE BEEN MADE TO THE THIRD-PARTY DISTRIBUTOR REPRESENTATIVE TO GATHER FURTHER INFORMATION WITHOUT SUCCESS, THEREFORE, THE INVESTIGATION WAS CONCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAME READY ACCELERATED RECOVERY SYSTEM 890.5720 WATER CIRCULATING COLD PACK ILO COOLSYSTEMS, INC. 500055 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other