BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREX ANILLO DE PLACER

    MDR report key: 7759199 · Received August 7, 2018

    Report

    Report Number
    3009722622-2018-00007
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    August 7, 2018
    Manufacturer
    RECKITT BENCKISER HEALTHCARE INT. LIMITED
    Product Code
    LKY
    UDI-DI
    00067981957525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. UPON REPORTING THE INCIDENT THE CONSUMER WAS ABLE TO PROVIDE DETAILS OF THE PRODUCT'S NAME, BATCH NUMBER, HOWEVER EXPIRY DATE WAS NOT PROVIDED, THEREFORE ENABLING RB TO REVIEW THE PROCESS RECORDS AND RELEASE TESTING RESULTS FROM THE POINT OF INITIAL MANUFACTURE AND CHECK RETAINED SAMPLES FOR THE SPECIFIC BATCH IDENTIFIED. THE PRODUCT LABELLING ALSO STATES THAT MISUSE OF A CONSTRICTION RING MAY CAUSE BRUISING, PAINFUL INJURY, OR PERMANENT DAMAGE TO THE PENIS. THE COMPANY'S ASSESSMENT IS SERIOUS WITH A RELATEDNESS OF POSSIBLE.

    Description of Event or Problem · 1

    DEPRESSION [DEPRESSION], BLEEDING DURING AND POST DEFECATION [RECTAL HAEMORRHAGE], PATIENT STARTED FEELING PAIN / PAIN WAS MORE INTENSE IN TESTICLES, ANUS AND PENIS [GENITAL PAIN], LACK OF PENIS SENSITIVITY [HYPOAESTHESIA], DIFFICULTY TO KEEP IT AS WELL EJACULATION PROBLEMS [EJACULATION DISORDER], DECREASED URINE FLOW [URINE FLOW DECREASED], FLACCIDITY [HYPOTONIA], PATIENT STARTED FEELING DISCOMFORT FROM THE LOWER ABDOMEN TO THE PENIS, GLANS AND PERINEUM REGION. [DISCOMFORT]. CASE DESCRIPTION: INITIAL REPORT, DATE 10-JUL-2018. RECEIVED FROM CONSUMER RELATIONS, (B)(6), (B)(4). SUSPECT PRODUCT: DUREX PLEASURE RING BATCH NO: 0D6125216. EXPIRY DATE: NOT PROVIDED. CASE (B)(4) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2017, A MALE PATIENT OF AN UNKNOWN AGE USED DUREX PLEASURE RING FOR APPROXIMATELY 20 MINUTES. AFTER USING IT HE STARTED FEELING PAIN AND DISCOMFORT FROM THE LOWER ABDOMEN TO THE PENIS, GLANS AND PERINEUM REGION. THE PAIN WAS MORE INTENSE IN HIS TESTICLES, ANUS AND PENIS. REPORTER ALSO STATED THAT DIFFERENT SYMPTOMS APPEARED DUE TO THE PAIN AND DISCOMFORT EXPLAINED BEFORE, SUCH AS; LACK OF PENIS SENSITIVITY, FLACCIDITY, IRREGULAR ERECTION AND DIFFICULTY TO KEEP IT AS WELL EJACULATION PROBLEMS, DECREASED URINE FLOW AND BLEEDING DURING AND POST DEFECATION. ALL OF THAT WAS ACCOMPANIED BY DEPRESSION AS A CONSEQUENCE OF ALL THE SYMPTOMS. TREATMENT CONTINUED AND TESTS WERE BEING CONDUCTED TO DISMISS OTHER POTENTIAL DAMAGE. TREATMENT HAD BEEN REPORTED BUT IT WAS UNCLEAR WHICH EVENTS WERE TREATED. THIS CASE HAS BEEN DEEMED SERIOUS DUE TO SERIOUS DETERIORATION IN STATE OF HEALTH OF PATIENT. FOLLOW UP HAS BEEN REQUESTED TO OBTAIN FURTHER INFORMATION. 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
    597991 DUREX ANILLO DE PLACER DUREX PLEASURE RING LKY RECKITT BENCKISER HEALTHCARE INT. LIMITED 0D6125216 00067981957525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other