BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR SCHOLL'S CUSTOM FIT ORTHOTICS CF 420

    MDR report key: 2593930 · Received May 21, 2012

    Report

    Report Number
    1031623-2012-00003
    Event Type
    Other
    Date Received
    May 21, 2012
    Report Date
    May 2, 2012
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    Product Code
    KNP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SERIOUS US SPONTANEOUS REPORT RECEIVED FROM A FEMALE CONSUMER AGE NOT PROVIDED AND INITIALS ANONYMIZED. MEDICAL HISTORY AND CONCOMITANT MEDICATION NOT PROVIDED. DR SCHOLL'S CUSTOM FIT ORTHOTICS CF 420 WERE WORN FOR AN UNK INDICATION. DATES OF PRODUCT USE NOT SPECIFIED. CONSUMER REPORTED BEING HOSPITALIZED AFTER PURCHASE OF PRODUCT. REASON FOR HOSPITALIZATION WAS NOT SPECIFIED BY THE CONSUMER. CONSUMER STATED SHE WAS "HOSPITALIZED (B)(6) AND HAVE NOW RETURNED TO "NORMAL". CONSUMER ALSO STATED THE PRODUCT "DID NOT WORK FOR ME". OUTCOME: RECOVERING / RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DR SCHOLL'S CUSTOM FIT ORTHOTICS CF 420 DR SCHOLL'S CUSTOM FIT ORTHOTICS KNP SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other