BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCS ACTIVECARE+SFT SYSTEM

    MDR report key: 8119511 · Received November 30, 2018

    Report

    Report Number
    9616558-2018-00003
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    October 18, 2016
    Report Date
    August 22, 2018
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MCS CUSTOMER CARE CENTER ON APRIL 18, 2018. IT PASSED INSPECTION BUT WAS SCRAPPED DUE TO AGE AND COSMETIC DAMAGE. THE SLEEVE USED BY THE PATIENT WAS NOT RETURNED FOR INSPECTION. MCS DID NOT BECOME AWARE OF THE 2016 INJURY UNTIL RECEIVING A LETTER FROM THE PATIENT IN AUGUST, 2018 REQUESTING A BILL WAIVER. THE PATIENT INJURY MAY HAVE RESULTED FROM NON-COMPLIANCE WITH THE INSTRUCTIONS FOR USE IN CHECKING OF THE SLEEVES DURING USE IN HOSPITAL. THE PATIENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING CAUTIONS: CAUTION: CHECK THE SKIN OF YOUR LEGS AT LEAST ONCE A DAY. IF YOU EXPERIENCE ANY DISCOMFORT, PAIN, SWELLING, BLISTERING, SENSATION CHANGES, SKIN IRRITATION, SKIN BREAKDOWN, OR ANY OTHER UNUSUAL REACTION, CONSULT YOUR PHYSICIAN IMMEDIATELY AND NOTIFY YOUR SERVICE PROVIDER. CAUTION: FOR THE FOLLOWING PATIENT GROUPS, ADDITIONAL CARE SHOULD BE TAKEN BY CHECKING SKIN AT LEAST THREE TIMES A DAY AND DOUBLE CHECKING THE POSITIONING AND PROPER ADJUSTMENT OF THE SLEEVE: ELDERLY, EXHAUSTED (MENTALLY OR PHYSICALLY), UNCONSCIOUS, PARALYZED, SUFFERING FROM TERMINAL CANCER, SUFFERING FROM SEVERE PERIPHERAL NEUROPATHY, SUFFERING FROM A DISEASE OF THE BLOOD VESSELS IN THE LEGS OR RECEIVING CONTINUOUS EPIDURAL THERAPY FOR PAIN REDUCTION.

    Description of Event or Problem · 1

    AFTER HIP SURGERY, PATIENT WAS MOVED TO A REHAB CENTER. WHILE THERE SHE USED MCS ACTIVECARE+SFT SYSTEM. THERE WERE BLISTERS FOUND ON BOTH LEGS THAT HAD TO BE TREATED BY A WOUND SPECIALIST WHERE THE MCS ACTIVECARE+SFT SYSTEM FIT ON THE LEG. THE PATIENT WAS THEN "GIVE" A DIFFERENT DEVICE TO USE BY HER DOCTOR AND QUIT USING THE MCS ACTIVECARE+SFT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959868 MCS ACTIVECARE+SFT SYSTEM COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS (DBN) LTD. A502B-0001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention