BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB CLEAR WATER BLOCK PLUS 30S

    MDR report key: 5375830 · Received January 19, 2016

    Report

    Report Number
    1000599868-2016-00001
    Event Type
    Injury
    Date Received
    January 19, 2016
    Report Date
    January 4, 2016
    Manufacturer
    SHANGHAI JOHNSON & JOHNSON LTD.
    Product Code
    MGO
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED ON 19-JAN-2016 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (BAB CLEAR WATER BLOCK PLUS 30S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REGULATORY AUTHORITY REPORT WAS RECEIVED ON (B)(6) 2016 FROM (B)(6) (B)(4) REPORTING FOR AN APPROXIMATELY (B)(6) MALE CONSUMER FROM (B)(6). THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING BAND-AID CLEAR WATERBLOCK 5 (ROUTE CUTANEOUS, LOT NUMBER 141204A 1217, EXPIRATION DATE, FREQUENCY AND INDICATION UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, HE DEVELOPED ANAPHYLACTIC REACTION. AFTER AN UNSPECIFIED DURATION, THE DEVICE WAS DISCONTINUED. THE OUTCOME OF EVENT WAS UNKNOWN. THIS REPORT WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36142 BAB CLEAR WATER BLOCK PLUS 30S CLOSURE, WOUND, ADHESIVE MGO SHANGHAI JOHNSON & JOHNSON LTD. NI 141204A1217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other