BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYN POLYISOPRENE CONDOM

    MDR report key: 6368476 · Received March 1, 2017

    Report

    Report Number
    1019632-2017-00005
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 17, 2017
    Report Date
    May 2, 2017
    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 03/01/2017 - AFTER AN INDICATION OF CUSTOMER INFECTION REQUIRING MEDICAL TREATMENT ON (B)(6), INITIAL REPORT FILING. MANUFACTURING HAS REVIEWED THE DEVICE HISTORY RECORD. NO OUT OF SPECIFICATION OR IN PROCESS DEVIATIONS NOTED. PRODUCT WAS RELEASED CONSISTENT WITH ALL INTERNAL SPECIFICATIONS. RETAINED SAMPLES DID INDICATE A SLIGHT ODOR. IN 2016 - TO DECREASE THE ODOR PROFILE, MODIFICATION TO THE IN LINE LEACHING PROCESS, EX DIP WASHING, AND ODOR MASKING AGENT WERE INTRODUCED TO ALLEVIATE THE COSMETIC ODOR OF THE CONDOMS. ON 05/02/2017: > A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PRODUCT WAS MANUFACTURED AND PROCESSED WITHIN SPECIFICATION. NO DEVIATIONS WERE NOTED IN THE PRODUCTION RECORD.> > MICRO TESTING OF RETAIN SAMPLES INDICATED THAT SAMPLES WERE WITHIN TEST SPECIFICATIONS > PROTEIN TESTING OF RETAINED SAMPLES WERE EVALUATED AND ARE WITHIN ACCEPTABLE LIMIT. > RETURNED SAMPLES FROM CUSTOMER WERE INSPECTED AND SLIGHT ODOR WAS DETECTED. > A MASKING AGENT ALONG WITH PROCESS ENHANCEMENTS FOR LEACHING PROCESS IN PRODUCTION TO LESSEN THIS COSMETIC AESTHETIC WAS CLEARED UNDER A 510K HAS SINCE BEEN IMPLEMENTED AND IS TO BE SHIPPED BY END OF JUNE 2017. NO OTHER ACTIONS TO TAKE PLACE.

    Additional Manufacturer Narrative · 1

    ON 03/01/2017 - AFTER AN INDICATION OF CUSTOMER INFECTION REQUIRING MEDICAL TREATMENT ON (B)(6), INITIAL REPORT FILING. MANUFACTURING HAS REVIEWED THE DEVICE HISTORY RECORD. NO OUT OF SPECIFICATION OR IN PROCESS DEVIATIONS NOTED. PRODUCT WAS RELEASED CONSISTENT WITH ALL INTERNAL SPECIFICATIONS. RETAINED SAMPLES DID INDICATE A SLIGHT ODOR. IN 2016 - TO DECREASE THE ODOR PROFILE, MODIFICATION TO THE IN LINE LEACHING PROCESS, EX DIP WASHING, AND ODOR MASKING AGENT WERE INTRODUCED TO ALLEVIATE THE COSMETIC ODOR OF THE CONDOMS.

    Description of Event or Problem · 1

    ON 03/01/2017 - CUSTOMER INDICATED THAT UPON OPENING THE PRODUCT, THE PRODUCT HAD A "FOUL SMELL". SEVERAL OTHER FOILED PRODUCTS FROM THE SAME CARTON HAD THE SAME SMELL. CUSTOMER INDICATED ON (B)(6) THAT PARTNER HAD AN INFECTION AND SOUGHT MEDICAL ATTENTION FOR TREATMENT OF INFECTION.

    Description of Event or Problem · 1

    ON 03/01/2017 - CUSTOMER INDICATED THAT UPON OPENING THE PRODUCT, THE PRODUCT HAD A "FOUL SMELL". SEVERAL OTHER FOILED PRODUCTS FROM THE SAME CARTON HAD THE SAME SMELL. CUSTOMER INDICATED ON (B)(6) THAT PARTNER HAD AN INFECTION AND SOUGHT MEDICAL ATTENTION FOR TREATMENT OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153192 SKYN POLYISOPRENE CONDOM POLYISOPRENE CONDOM MOL SURETEX PROPHYLACTICS (I), LTD 1606P40922

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention