BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYN POLYISOPRENE MALE CONDOM

    MDR report key: 6045113 · Received October 20, 2016

    Report

    Report Number
    1019632-2016-00010
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 13, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SURETEX PROPHYLACTICS (I), LTD.
    Product Code
    MOL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/20/2017: USER CONTACTED ANSELL ON (B)(6) 2016 INDICATED A REACTION ISSUE WITH PRODUCT WITHOUT FURTHER INFORMATION TO THE REACTION. EMAIL CORRESPONDENCE TO THE END USER SEEKING MORE INFORMATION ON THE INCIDENT WAS RESPONDED ON (B)(6) 2016 TO INDICATED THAT ONE MONTH EARLIER HE AND HIS GIRLFRIEND USED A CONDOM AND LATER IN THE MONTH, ANOTHER CONDOM, AND BOTH TIME THE PARTNER DEVELOPED A URINARY TRACT INFECTION. ANSELL WAS ADVISED THAT PARTNER WAS PRESCRIBED MACROBID FOR THE INFECTION.

    Additional Manufacturer Narrative · 1

    ON 10/20/2016 - USER CONTACTED ANSELL ON 9/13/2016 INDICATED A REACTION ISSUE WITH PRODUCT WITHOUT FURTHER INFORMATION TO THE REACTION. EMAIL CORRESPONDENCE TO THE END USER SEEKING MORE INFORMATION ON THE INCIDENT WAS RESPONDED ON 10/13/2016 TO INDICATED THAT ONE MONTH EARLIER HE AND HIS GIRLFRIEND USED A CONDOM AND LATER IN THE MONTH, ANOTHER CONDOM, AND BOTH TIME THE PARTNER DEVELOPED A URINARY TRACT INFECTION. ANSELL WAS ADVISED THAT PARTNER WAS PRESCRIBED MACROBID FOR THE INFECTION. ON 12/01/2016: DEVICE HISTORY RECORD OF THE LOT WAS ANALYZED WITH RESPECT TO THE REPORTED COMPLAINT. THE LOT WAS PRODUCED USING SYNTHETIC POLYISOPRENE WITH EXISTING COMPOUNDING FORMULATION AND THERE IS NO CHANGE IN DOSAGE OR CHANGE OF RAW MATERIALS AND CHEMICALS USED .THERE IS ALSO NO CHANGE IN CHEMICALS USED IN THE VARIOUS STAGES OF THE MANUFACTURING PROCESS. THE LOT WAS INSPECTED AT VARIOUS STAGES OF MANUFACTURING PROCESS AND RELEASED AS PER THE DOCUMENTED QUALITY PLAN. EACH PROCESS OUTPUT WAS TESTED AND VERIFIED FOR CONFORMANCE AGAINST THE QUALITY PLAN. THE LOT WAS LUBRICATED WITH SILICONE LUBRICANT AS PER THE BRAND SPECIFICATION. THE LUBRICANT USED IN THE LOT IS SUPPLIER BY AN APPROVED SUPPLIER. LOT NO: 1601P21622, IN PROCESS LUBRICANT QTY (MG): MIN: 480, MAX: 560, MEAN: 553. FINISHED PRODUCT LUBRICANT QTW (MG): MIN: 511, MAX:587. NO LUBRICANT AND DRY PRODUCTS WERE OBSERVED DURING THE FOILING PROCESS AND FINAL RELEASE INSPECTION AND SAMPLING. THE BATCHES MET THE LUBRICANT SPECIFICATION INSPECTION OF RETAINED SAMPLES: 13 PCS OF RETAINED SAMPLES WERE TESTED FOR MICROBIAL TESTING. ALL THE SAMPLE RESULTS ARE WITHIN THE MICROBIAL TEST SPECIFICATION: (B)(6). INSPECTION OF CUSTOMER RETURNED SAMPLES. TEN (10) PCS RETURNED AND TEST FOR LUBRICANT QTY 1601P21622: MIN: 490, MAX: 563, MEAN: 5528. NO ANOMALIES DETERMINED; NO ASSIGNABLE CAUSE CAN BE FOUND FROM CUSTOMER RETURNED SAMPLES. NO FURTHER ACTION CAN BE TAKEN.

    Description of Event or Problem · 1

    ON 10/20/2017: USER CONTACTED ANSELL ON (B)(6) 2016 INDICATED A REACTION ISSUE WITH PRODUCT WITHOUT FURTHER INFORMATION TO THE REACTION. EMAIL CORRESPONDENCE TO THE END USER SEEKING MORE INFORMATION ON THE INCIDENT WAS RESPONDED ON (B)(6) 2016 TO INDICATED THAT ONE MONTH EARLIER HE AND HIS GIRLFRIEND USED A CONDOM AND LATER IN THE MONTH, ANOTHER CONDOM, AND BOTH TIMES THE PARTNER DEVELOPED A URINARY TRACT INFECTION. ANSELL WAS ADVISED THAT PARTNER WAS PRESCRIBED MACROBID FOR THE INFECTION.

    Description of Event or Problem · 1

    ON 10/20/2016 - USER CONTACTED ANSELL ON (B)(6) 2016 INDICATED A REACTION ISSUE WITH PRODUCT WITHOUT FURTHER INFORMATION TO THE REACTION. EMAIL CORRESPONDENCE TO THE END USER SEEKING MORE INFORMATION ON THE INCIDENT WAS RESPONDED ON 10/13/2016 TO INDICATED THAT ONE MONTH EARLIER HE AND HIS GIRLFRIEND USED A CONDOM AND LATER IN THE MONTH, ANOTHER CONDOM, AND BOTH TIME THE PARTNER DEVELOPED A URINARY TRACT INFECTION. ANSELL WAS ADVISED THAT PARTNER WAS PRESCRIBED MACROBID FOR THE INFECTION. ON 12/01/2016 - USER SENT SAMPLES IN FOR INVESTIGATION ON 10/24/2016 WHICH AS SENT ON THE MANUFACTURING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696390 SKYN POLYISOPRENE MALE CONDOM SYNTHETIC POLYISOPRENE MALE CONDOM MOL SURETEX PROPHYLACTICS (I), LTD. 1601P21622

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other