BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFILTRALONG

    MDR report key: 23645277 · Received November 25, 2025

    Report

    Report Number
    9611612-2025-00049
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    July 1, 2025
    Report Date
    December 18, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSO
    PMA / PMN Number
    K080675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2025-11-25 MORE DETAILED INFORMATION ABOUT THE AFFECTED MODEL WERE SUBMITTED, SO WE COULD TRACE BACK IF THIS DEVICE MODEL WAS SOLD TO THE USA. SO, DECISION WAS MADE TO REPORT THIS CASE TO THE FDA ON 2025-11-25. FURTHER INFORMATION E.G. DETAILED ITEM NUMBER AND LOT NUMBER WERE REQUESTED. SHOULD YOU HAVE ANY QUESTIONS, PLEASE DO NOT HESITATE TO CONTACT US AT THE FOLLOWING EMAIL ADDRESS: [email protected]. 2025-12-18: EVALUATION OF COMPLAINT WAS ADDED AND THE IMDRF CODES FOR THE ANALYSIS UPDATED. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 MORE DETAILED INFORMATION ABOUT THE AFFECTED MODEL WERE SUBMITTED, SO WE COULD TRACE BACK IF THIS DEVICE MODEL WAS SOLD TO THE USA. SO, DECISION WAS MADE TO REPORT THIS CASE TO THE FDA ON (B)(6) 2025. FURTHER INFORMATION E.G. DETAILED ITEM NUMBER AND LOT NUMBER WERE REQUESTED. SHOULD YOU HAVE ANY QUESTIONS, PLEASE DO NOT HESITATE TO CONTACT US AT THE FOLLOWING EMAIL ADDRESS: (B)(6). INVESTIGATIONS ARE ONGOING. WHEN THE INCIDENT WAS INVESTIGATED IN DETAIL A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN UK. AS THE WOUND CATHETER WAS BEING REMOVED FROM THE PATIENT, THE CATHETER CASING CAME AWAY AND THE WIRE INSIDE BECAME EXPOSED, THIS THEN SNAPPED AND REMAINED INSIDE THE PATIENT. THE PATIENT THEN HAD TO GO FOR EMERGENCY SURGERY TO HAVE IT REMOVED.

    Description of Event or Problem · 0

    IRN#(B)(4). INCIDENT OCCURRED IN UK. AS THE WOUND CATHETER WAS BEING REMOVED FROM THE PATIENT, THE CATHETER CASING CAME AWAY AND THE WIRE INSIDE BECAME EXPOSED, THIS THEN SNAPPED AND REMAINED INSIDE THE PATIENT. THE PATIENT THEN HAD TO GO FOR EMERGENCY SURGERY TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832694 INFILTRALONG INFILTRALONG BSO PAJUNK GMBH MEDIZINTECHNOLOGIE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention