BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREX PLEASURE RING

    MDR report key: 6577135 · Received May 18, 2017

    Report

    Report Number
    3009722622-2017-00004
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 5, 2017
    Manufacturer
    RECKITT BENCKISER HEALTHCARE INT LIMITED
    Product Code
    LKY
    UDI-DI
    00067981957525
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RB IS AWAITING THE RETURN OF THE PRODUCT FOR QUALITY ANALYSIS AND ALSO FOLLOW UP INFORMATION REGARDING THE REPORTED INCIDENT. THE PATIENT DID SPECIFY THE VARIETY OF DUREX THAT WAS USED AS DUREX PLEASURE RING. THE PATIENT NEITHER PROVIDES THE BATCH DETAILS FOR THE PRODUCT NOR RETURNED ANY OF THE REMAINING UNOPENED PRODUCT FOR QUALITY ANALYSIS. FURTHER INFORMATION IS EXPECTED. THE PRODUCT LABELLING ALSO STATES THAT "IF USING THIS RING FEELS UNCOMFORTABLE OR HURTS, STOP AND TAKE IT OFF. STORE IT IN A COOL, DRY PLACE AWAY FROM DIRECT SUNLIGHT." THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELATEDNESS OF POSSIBLE.

    Description of Event or Problem · 1

    INITIAL REPORT, RECEIVED DATE: 05-MAY-2017. RECEIVED FROM CONSUMER RELATIONS, COUNTRY: (B)(6). BATCH NO AND EXPIRY DATE: NOT PROVIDED. CASE REFERENCE NUMBER (B)(4) IS A REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2017 (3 DAYS BEFORE REPORTING), A MALE PATIENT OF AN UNKNOWN AGE USED DUREX PLEASURE RING. HE SAID AFTER 10-15 MINUTES OF USING PRODUCT, HE HAD LOST ANY FEELINGS IN HIS PENIS AND HIS ERECTION HAD DISAPPEARED. HE HAS ALL MEDICAL DOCUMENTS FROM HOSPITAL THAT CAN CONFIRM THAT AFTER USING PRODUCT, NERVES IN HIS PENIS WERE DAMAGED. HE NEEDED TO UNDERGO LONG-TERM TREATMENT. HE SAID THAT AT THIS MOMENT DOCTORS COULD NOT TELL HIM IF HE WOULD EVER RECOVER. THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELATEDNESS OF POSSIBLE AND UNANTICIPATED. CASE OUTCOME: NOT RECOVERED / NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357067 DUREX PLEASURE RING DEVICE, EXTERNAL PENILE RIGIDITY LKY RECKITT BENCKISER HEALTHCARE INT LIMITED 5011417565162 00067981957525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other