BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-LINE HERNIA MESH

    MDR report key: 16721473 · Received April 11, 2023

    Report

    Report Number
    3017492634-2023-00001
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 11, 2023
    Manufacturer
    DEEP BLUE MEDICAL ADVANCES, INC.
    Product Code
    FTL
    UDI-DI
    00850002394009
    PMA / PMN Number
    K221556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION INCLUDING REVIEW OF MANUFACTURING RECORDS AND INTERVIEWS WITH THE PATIENT AND THEIR DOCTOR, IT WAS DETERMINED TO BE A STREPTOCOCCUS INFECTION AT THE SITE OF THE INCISION. THE PATIENT'S MEDICATION WAS CHANGED AND AS OF A FOLLOW UP WITH THE DOCTOR ON (B)(6) 2023, THE DOCTOR STATED THAT THE PATIENT IS RESPONDING VERY WELL TO THE ANTIBIOTICS. HE FURTHER STATED THAT HE DID NOT BELIEVE THE INFECTION WAS DUE TO ANY MESH ALLERGY OR OTHER MESH ISSUE, AND THAT IT WILL RESOLVE COMPLETELY WITH THE ANTIBIOTICS.

    Description of Event or Problem · 0

    ON 3/8/2023, AN EMAIL INQUIRY FROM THE DEEP BLUE WEBSITE FROM A BH ASKING FOR THE DEEP BLUE PHONE NUMBER SO HE COULD FILE AN ADVERSE EVENT. ADDITIONALLY, ON THE SAME DAY MR. PERRY, DEEP BLUE'S CEO CONTACTED DR. SAXE. DR. SAXE CONFIRMED THAT BH IS A PATIENT OF HIS. HE STATED THAT BH HAD REDNESS AND ITCHINESS ON HIS SKIN OVER A LARGE PART OF HIS ABDOMEN. HE MENTIONED THE PATIENT HAD NO PAIN, ONLY ITCHINESS OF THE SKIN. HE MENTIONED THE PATIENT WAS HEALING WELL FROM THE SURGERY AND DID NOT HAVE ANY ISSUES WITH INFECTION OR SURGICAL HEALING THAT HE COULD TELL. HE WONDERED IF IT WAS AN ALLERGIC REACTION TO POLYPROPYLENE. HE WAS GOING TO FOLLOW-UP ON THE PATIENT AND SEE HOW IT PROGRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008588 T-LINE HERNIA MESH HERNIA MESH FTL DEEP BLUE MEDICAL ADVANCES, INC. TL1507 A2112002 00850002394009

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other