BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPONGOSTAN¿ ABSORBABLE HAEMOSTATIC GELATIN SPONGE, STANDARD

    MDR report key: 24854294 · Received April 13, 2026

    Report

    Report Number
    3008478369-2026-00005
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOW WAS THE PRODUCT STORED? THE PRODUCT WAS STORED IN THE OR PASS-THROUGH CABINET IN AN OPEN PLASTIC CONTAINER. WHERE WAS THE PRODUCT STORED? IN THE OR PASS-THROUGH CABINET. COULD THE POUCH BE OPENED IN AN ASEPTIC MANNER? NO. THE PAPER PACKAGING STARTED TO TEAR. THE PAPER OF THE OUTER PACKAGE TEARS IN A WAY THAT THE PAPER BECOMES "TRANSLUCENT." IT DOES NOT PRIMARILY TEAR ALONG THE SIDE SEAMS. WAS IT THE OUTER POUCH THAT WAS RIPPED DURING OPENING? YES. IT STARTED TO TEAR, AND THEREFORE THE CONTENTS OF THE PACKAGE BECAME CONTAMINATED. WAS IT THE INNER POUCH THAT WAS RIPPED DURING OPENING? I WAS ABLE TO OPEN THE INNER PACKAGE, BUT IT MUST BE DONE CAREFULLY, AS THE INNER PACKAGE OPENS DIFFERENTLY FROM THE OUTER ONE. WAS THE PRODUCT USED ON THE PATIENT? YES, IT WAS USED AFTER THE INNER PACKAGE COULD BE OPENED. WAS THE SURGERY DELAYED BECAUSE OF THE MALFUNCTION? YES. SOMETIMES ONLY THE THIRD PACKAGE OPENS WITHOUT BREAKING. IF YES, HOW MANY MINUTES? 1-1.5 MINUTES. WAS THERE ANY PATIENT/USER HARM OR POTENTIAL PATIENT/USER HARM BECAUSE OF THE MALFUNCTION? FRUSTRATION FOR THE NURSE, AS THE PACKAGES TEAR FREQUENTLY. THE PACKAGE SEAMS ARE TOO DRY. INITIAL EVENT DESCRIPTION: THE PACKAGE DOES NO OPEN NORMALLY, IT TEARS DURING OPENING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE AFFILIATE ON 03.04.2026 STATING: AS I UNDERSTOOD FROM HEALTHCARE PROFFESIONAL, THAT THE OUTER POUCH DID NOT OPEN IN AN ASEPTIC MANNER SO SHE TOOK THE INNER POUCH AND TRIED TO OPEN IT IN ASEPTIC MANNER AND THAT IS HOW THE PRODUCT WAS HANDLED TO THE STERILE AREA IN AN ASEPTIC MANNER. WE HAD A REALLY LONG PERIOD OF VERY COLD WEATHER HERE IN (B)(6) DURING THIS WINTER. I THINK THE HOSPITAL AIR QUALITY INSIDE THE OR HAS BEEN VERY DRY AND THAT IS THE REASON THE SPONGOSTAN PAPER POUCH HAS BEEN VERY DRY TOO. THE INSIDE AIR HAS AFFECTED THE PAPER IN THE PRODUCT. AND WHEN IT'S DRY IT IS VERY HARD TO OPEN. THE COMPLAINTS KEPT COMING DURING THE VERY COLD WEEKS BUT NO COMPLAINTS AFTER THE WEATHER GOT A BIT WARMER. I HAD A CONVERSATION HEALTHCARE PROFFESIONAL. THE OUTER POUCH RIPPED DURING THE OPENING SO IT WAS NOT POSSIBLE TO OPEN IN AN ASEPTIC MANNER. SO SHE TOOK THE INNER POUCH AN OPENED IT VERY CAREFULLY WITHOUT TOUCHING TO THE SPONGOSTAN PRODUCT AND WAS ABLE TO OPEN IT IN AN ASEPTIC MANNER. AND THE INSTRUMENT NURSE WHO WAS STERILE WAS ABLE TO TAKE THE PRODUCT IN AN ASEPTIC MANNER TO THE STERILE AREA. HOPEFULLY THIS CLEARS OUT THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922633 SPONGOSTAN¿ ABSORBABLE HAEMOSTATIC GELATIN SPONGE, STANDARD Agent, absorbable hemostatic, collagen based LMF FERROSAN MEDICAL DEVICES A/S MS0002 281524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown