BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMEDIOX

    MDR report key: 19563720 · Received June 18, 2024

    Report

    Report Number
    3007895168-2024-00011
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 10, 2024
    Manufacturer
    DEMETECH CORPORATION
    Product Code
    NEW
    UDI-DI
    10652927777489
    PMA / PMN Number
    K082097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR 3007895168-2024-00011-001 BRAND NAME: DEMEDIOX VERSION OR MODEL: PX2X783090A16MB. COMPANY NAME: DEMETECH CORPORATION. PRIMARY DI NUMBER: (B)(4). DEVICE DESCRIPTION: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE FDA PREMARKET SUBMISSION NUMBER: K082097.

    Description of Event or Problem · 0

    HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON 04/22/2024, ACCORDING TO THE HCP, PATIENT CAME IN FOR A FOLLOW-UP 10 DAYS POST PROCEDURE WITH BUNCHING UNDER THE PATIENT'S RIGHT EYE, NEAR THE NOSE. PATIENT DID NOT REPORT ANY PAIN AT THE TIME, BUT FELT SOME PINCHING FROM TIME TO TIME. HCP DECIDED TO LEAVE THE THREAD INSIDE THE PATIENT AND TO MASSAGE IT UNTIL NOT VISIBLE, AS IT WAS NOT AFFECTING THE PATIENT. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT PRESENTED WITH MORE BUNCHING NEAR THE RIGHT SIDE OF THE NOSE UNDER THE EYE. PATIENT FELT "POKING" AND SOMETIMES PAIN. HCP FELT A THREAD GOING PAST THE PATIENT'S ORBITAL RIM, INTO THE EYE SOCKET. HCP REMOVED THE THREAD. ON 06/12/2024, HCP REPORTED THAT THE PATIENT IS DOING PERFECTLY FINE, AND THAT NO ADDITIONAL FOLLOW-UP IS NEEDED.

    Description of Event or Problem · 0

    HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, ACCORDING TO THE HCP, PATIENT CAME IN FOR A FOLLOW-UP 10 DAYS POST PROCEDURE WITH BUNCHING UNDER THE PATIENT'S RIGHT EYE, NEAR THE NOSE. PATIENT DID NOT REPORT ANY PAIN AT THE TIME, BUT FELT SOME PINCHING FROM TIME TO TIME. HCP DECIDED TO LEAVE THE THREAD INSIDE THE PATIENT AND TO MASSAGE IT UNTIL NOT VISIBLE, AS IT WAS NOT AFFECTING THE PATIENT. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT PRESENTED WITH MORE BUNCHING NEAR THE RIGHT SIDE OF THE NOSE UNDER THE EYE. PATIENT FELT "POKING" AND SOMETIMES PAIN. HCP FELT A THREAD GOING PAST THE PATIENT'S ORBITAL RIM, INTO THE EYE SOCKET. HCP REMOVED THE THREAD. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT IS DOING PERFECTLY FINE, AND THAT NO ADDITIONAL FOLLOW-UP IS NEEDED. UPDATE: ON (B)(6) 2024, HCP WAS CONTACTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION. ON (B)(6) 2024, ANOTHER FOLLOW-UP WITH THE HCP WAS CONDUCTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION. HCP PROVIDED THE IMPLANTED DATE OF (B)(6) 2024. ON (B)(6) 2024, HCP PROVIDED PICTURES OF THE PATIENT.

    Description of Event or Problem · 0

    HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, ACCORDING TO THE HCP, PATIENT CAME IN FOR A FOLLOW-UP 10 DAYS POST PROCEDURE WITH BUNCHING UNDER THE PATIENT'S RIGHT EYE, NEAR THE NOSE. PATIENT DID NOT REPORT ANY PAIN AT THE TIME, BUT FELT SOME PINCHING FROM TIME TO TIME. HCP DECIDED TO LEAVE THE THREAD INSIDE THE PATIENT AND TO MASSAGE IT UNTIL NOT VISIBLE, AS IT WAS NOT AFFECTING THE PATIENT. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT PRESENTED WITH MORE BUNCHING NEAR THE RIGHT SIDE OF THE NOSE UNDER THE EYE. PATIENT FELT "POKING" AND SOMETIMES PAIN. HCP FELT A THREAD GOING PAST THE PATIENT'S ORBITAL RIM, INTO THE EYE SOCKET. HCP REMOVED THE THREAD. ON 06/12/2024, HCP REPORTED THAT THE PATIENT IS DOING PERFECTLY FINE, AND THAT NO ADDITIONAL FOLLOW-UP IS NEEDED. UPDATE: ON 06/18/2024, HCP WAS CONTACTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION. ON 06/26/2024, ANOTHER FOLLOW-UP WITH THE HCP WAS CONDUCTED TO PROVIDE PICTURES OF THE PATIENT AND ADDITIONAL INFORMATION. HCP PROVIDED THE IMPLANTED DATE OF (B)(6) 2024. ON (B)(6) 2024, HCP PROVIDED PICTURES OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655371 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X783090A16MB L107-22 10652927777489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention