BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR FOG TREATED SPONGE, STERILE

    MDR report key: 17663320 · Received August 31, 2023

    Report

    Report Number
    1836161-2023-00029
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    OCT
    PMA / PMN Number
    K932449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. IT WAS FOUND THAT THE PROTRUSION BAR USED TO DETECT OUR OF POCKET PARTS ON THE PRODUCTION LINE WILL PUSH THE TREATED SPONGE PRODUCT OUT OF THE POCKETS IF THE PLASTIC BACKING ON THE SPONGE IS WARPED. ROOT CAUSE WAS A MACHINE ERROR. OPERATORS BOXING THE SPONGES SHOULD ALSO DETECT SEAL ERRORS DURING PACKAGING. THIS WAS REVIEWED WITH THE PRODUCTION TEAM. WE WILL CONTINUE TO MONITOR THE SITUATION FOR ANY ADDITIONAL RELEVANT INFORMATION. THIS REPORT CAN BE CONSIDERED FINAL, HOWEVER IF WE DISCOVER ANY ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES, AND THIS AFFECTED TWO LOTS OF PRODUCT. THE ACTUAL DEVICES WERE NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBERS WERE PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW AS WELL. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT TWO DR FOG SPONGES WERE DISCOVERED WITH SEALING ISSUES. THE ITEMS WERE NOT IN USE. NO INJURY/DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBERS AND RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4) (LOT 332539) AND (B)(4) (LOT 333609).

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT TWO DOCTOR FOG SPONGES WERE DISCOVERED WITH SEALING ISSUES. THE ITEMS WERE NOT IN USE. NO INJURY/DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBER AND RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: C-1183170 (LOT 332539), C-1183171 (LOT 333609).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603572 DR FOG TREATED SPONGE, STERILE ANTI-FOG OCT ASPEN SURGICAL PRODUCTS, CALEDONIA DF-3120 332539, 333609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown