BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX PEC IMPLANT

    MDR report key: 12307523 · Received August 11, 2021

    Report

    Report Number
    2031444-2021-00001
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    March 8, 2021
    Report Date
    August 10, 2021
    Manufacturer
    HANSON MEDICAL, INC.
    Product Code
    MIC
    UDI-DI
    B049ACP220
    PMA / PMN Number
    K973729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT HAD HANSON MEDICAL PECTORALIS IMPLANTS (HMI PART # ACP 2 - 2, PAIR / LOT # 18309) IMPLANTED ON (B)(6) 2021 BY DR. (B)(6). THE COMPLAINT NOTES INDICATE THAT THE PECTORALIS IMPLANTS WERE STERILIZED AT THE SURGERY CENTER, HOWEVER, NO RECORD OR METHOD OF STERILIZATION COULD BE PROVIDED. THE PATIENT COMPLAINED NUMEROUS TIMES TO DR. (B)(6) THAT HE WAS EXPERIENCING A RASH (BILATERALLY) WHICH WAS PROGRESSING EXTENSIVELY. THE PATIENT WAS TREATED WITH MEDROL DOSEPAK AND ANTIBIOTICS WITH NO IMPROVEMENT. THE PATIENT HAD SUBSEQUENT OFFICE VISITS ON (B)(6) 2021. THE IMPLANTS WERE REMOVED (EXPLANTED) ON (B)(6) 2021. HANSON MEDICAL WAS FIRST NOTIFIED OF THIS ISSUE ON JULY 12, 2021. HANSON MEDICAL (HMI) REVIEWED THE COMPLAINT NOTES AND EMAILS, TRACED THE SHIPPING LOG ((B)(6) 2021), BATCH MANUFACTURING RECORD ((B)(4)), PACKAGE INSERT ((B)(4)), AND INCOMING INSPECTION OF RAW MATERIALS ((B)(4)). THE INCOMING INSPECTION RECORD SHOWS THE RAW MATERIAL PASSED ALL CYTOTOXICITY TESTS AND ELEMENTAL ANALYSIS OF TRACE METALS PRIOR TO RELEASE. THE PACKAGE INSERT SPECIFIES THE THREE APPROVED STEAM STERILIZATION CYCLES FOR HMI BODY CONTOURING IMPLANTS AND STATES "NEVER USE ETO ETHYLENE OXIDE STERILIZATION TO STERILIZE THIS PRODUCT." THE INVESTIGATION DOES NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED ADVERSE EVENT. HOWEVER, HMI HAS DETERMINED THAT "THE DEVICE APPEARS TO ELICIT AN UNDESIRED RESPONSE IN THE PATIENT TO THE PRESENCE OF AN IMPLANTED OR INVASIVE DEVICE, WITHOUT INHERENT DEVICE FAILURE." THE PATIENT'S RASH IMPROVED AFTER EXPLANTATION.

    Description of Event or Problem · 1

    A PATIENT HAD HANSON MEDICAL PECTORALIS IMPLANTS (HMI PART # ACP 2 - 2, PAIR / LOT # 18309) IMPLANTED ON (B)(6) 2021 BY DR. (B)(6). THE COMPLAINT NOTES INDICATE THAT THE PECTORALIS IMPLANTS WERE STERILIZED AT THE SURGERY CENTER, HOWEVER, NO RECORD OR METHOD OF STERILIZATION COULD BE PROVIDED. THE PATIENT COMPLAINED NUMEROUS TIMES TO DR. SHAH THAT HE WAS EXPERIENCING A RASH (BILATERALLY) WHICH WAS PROGRESSING EXTENSIVELY. THE PATIENT WAS TREATED WITH MEDROL DOSEPAK AND ANTIBIOTICS WITH NO IMPROVEMENT. THE PATIENT HAD SUBSEQUENT OFFICE VISITS ON (B)(6) 2021. THE IMPLANTS WERE REMOVED (EXPLANTED) ON (B)(6) 2021. HANSON MEDICAL WAS FIRST NOTIFIED OF THIS ISSUE ON JULY 12, 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205320 POWERFLEX PEC IMPLANT PECTORALIS IMPLANT MIC HANSON MEDICAL, INC. ACP 2 - 2, PAIR 18309 B049ACP220

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O