BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDISC TM PERF PATCH KIT

    MDR report key: 17417771 · Received July 28, 2023

    Report

    Report Number
    3003668467-2023-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    January 1, 2022
    Report Date
    September 1, 2023
    Manufacturer
    ANIKA THERAPEUTICS S.R.L.
    Product Code
    KHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS NOT CONFIRMED. ADDITIONAL INFORMATION COULD NOT BE OBTAINED. THE CAUSE OF THE REPORTED EVENT IS NOT CONFIRMED. HOWEVER, BASED ON PREVIOUS INVESTIGATIONS, A PLAUSIBLE CAUSE IS USE ERROR. THE USER DID NOT SEE THE SHELF LIFE ADDENDUM IN THE BOX. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS ONE PLANNED DEVIATION AND NO NON-CONFORMANCES DOCUMENTED IN THE PRODUCT RECORD. THE PLANNED DEVIATION WAS FOR "RE-LABELING OF THE ALREADY RELEASED BATCHES TO EXTEND SLED AT 36 MONTHS." PRODUCT WAS RELEASED ON 24JUL2020 AND EXPIRES ON 22APR2022. INCLUDED WITH THE BATCH RECORD WAS AN ADDENDUM ALERTING THE USER THAT THE SHELF LIFE HAS BEEN EXTENDED IS INCLUDED IN THE LABELING. THERE WAS NO NONCONFORMANCES OR DEVIATIONS RELATED TO THE LABELING OF THIS LOT. THE PRODUCT WAS RELEASED TO SPECIFICATION. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVE OF NEW AND RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 07JULY2023 A MEDWATCH REPORT WAS LOCATED DURING SURVIELLANCE WHICH WAS REPORTED TO THE FDA ON 19JAN2022. THE FOLLOWING WAS REPORTED ON THE MEDWATCH (MW13415382) REPORT: THERE IS A DISCREPANCY WITH THE EXPIRATION DATES FOR THE EPIDISC T. M PERFORATION PATCH KIT (REF 1417151) AND EPIDISC OTOLOGIC 8 MM (REF 1417151). THE OUTER BOX AND PLASTIC SLEEVE HAVE A DIFFERENT EXPIRATION DATE THAN THAT OF THE ACTUAL IMPLANT. IN THIS CASE THE IMPLANT WAS EXPIRED. I HAVE 7 BOXES THAT SHOW AN APPROPRIATE EXPIRATION DATE, WITH THE INTERNAL IMPLANT BEING EXPIRED. MANUFACTURER RESPONSE FOR EPIDISC T. M. AND EPIDISC OTOLOGIC 8 MM, (BRAND NOT PROVIDED) (PER SITE REPORTER): MEDTRONIC RESTORATIVE THERAPIES GROUP ENT". THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR DELAY IN THE PROCEDURE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 07JULY2023 A MEDWATCH REPORT WAS LOCATED DURING SURVIELLANCE WHICH WAS REPORTED TO THE FDA ON 19JAN2022. THE FOLLOWING WAS REPORTED ON THE MEDWATCH (MW13415382) REPORT: THERE IS A DISCREPANCY WITH THE EXPIRATION DATES FOR THE EPIDISC T. M PERFORATION PATCH KIT (REF (B)(4) AND EPIDISC OTOLOGIC 8 MM (REF (B)(4).THE OUTER BOX AND PLASTIC SLEEVE HAVE A DIFFERENT EXPIRATION DATE THAN THAT OF THE ACTUAL IMPLANT. IN THIS CASE THE IMPLANT WAS EXPIRED. I HAVE 7 BOXES THAT SHOW AN APPROPRIATE EXPIRATION DATE, WITH THE INTERNAL IMPLANT BEING EXPIRED. MANUFACTURER RESPONSE FOR EPIDISC T. M. AND EPIDISC OTOLOGIC 8 MM, (BRAND NOT PROVIDED) (PER SITE REPORTER): MEDTRONIC RESTORATIVE THERAPIES GROUP ENT". THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814986 EPIDISC TM PERF PATCH KIT POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) KHJ ANIKA THERAPEUTICS S.R.L. 0000002552R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown