BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 19462174 · Received June 4, 2024

    Report

    Report Number
    2245270-2024-00047
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    April 29, 2024
    Report Date
    September 11, 2024
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017584
    PMA / PMN Number
    K122834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICES WILL BE RETURNED TO THE MANUFACTURER AND UPON RECEIPT, AN INVESTIGATION WILL BE CONDUCTED. FDA WILL BE NOTIFIED OF THE RESULTS UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE DATE OF THE EVENT SHOULD BE APRIL 29, 2024 NOT MAY 30, 2024. THE PREVIOUS INITIAL REPORT LISTED MAY 30, 2024. ERRONEOUSLY. THERE WERE TWO OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: MDR 2245270-2024-00047. MDR 2245270-2024-00048. THE REVIEW OF THE MANUFACTURING BATCH RECORDS OF THE POLYSITE 3017SPI IMPLANTABLE PORT FINAL PRODUCT (BATCH 23040046 AND BATCH 22050001) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. THE RESULTS OF THE TESTS CARRIED OUT ON THE TWO RETURNED DEVICES DID NOT REVEAL ANY DEFECT THAT COULD HAVE CAUSED THE PROBLEM DESCRIBED IN THIS COMPLAINT "PORT ERODING THROUGH THE SKIN". THERE WAS NO FURTHER INFORMATION PROVIDED BY THE HOSPITAL REGARDING THIS COMPLAINT "PORT ERODING THROUGH THE SKIN". THE MOST LIKELY HYPOTHESIS THAT COULD EXPLAIN THE EXTERNALISATION PHENOMENON FROM THE IMPLANTABLE PORT COULD BE: - THE USE OF AN IMPLANTABLE PORT NOT ADAPTED TO THE PATIENT'S MORPHOLOGY (DIMENSION (TOO LARGE), MATERIAL, INDICATION, ...), - AN IMPLANTABLE PORT LOCATED LESS THAN 1 CM FROM THE SKIN, - WEIGHT LOSS OF THE PATIENT, - THE WEAKENING OF THE PATIENT'S SKIN BY CHEMO PRODUCTS. UNFORTUNATELY, WITHOUT ADDITIONAL INFORMATION AND REGARDING OUR INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THESE HYPOTHESIS. PEROUSE MEDICAL HAS NOT BEEN INFORMED OF ANOTHER INCIDENT INVOLVING LOT 23040046. PEROUSE MEDICAL HAS NOT BEEN INFORMED OF ANOTHER INCIDENT INVOLVING LOT 22050001. IN CONCLUSION AND ACCORDING TO THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE PRECISELY DETERMINED.

    Description of Event or Problem · 0

    PORT ERODING THROUGH THE SKIN. PORT WAS REMOVED.

    Description of Event or Problem · 0

    PORT ERODING THROUGH THE SKIN. PORT WAS REMOVED. PT WILL REQUIRE NEW ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610026 POLYSITE POLYSITE PRESSURE INJECTABLE INFUSION PORT WITH SILICONE-FILLED SUTURE LJT PEROUSE MEDICAL 3017SPI 23040046 03661234017584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention