BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN STAPLER 35W

    MDR report key: 19951731 · Received August 9, 2024

    Report

    Report Number
    1060680-2023-00016
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    December 6, 2023
    Report Date
    May 3, 2024
    Manufacturer
    TELEFLEX LLC
    Product Code
    QQS
    UDI-DI
    50749756024377
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001." THIS MDR REPRESENTS ONE OF THE FOUR INSTANCES DESCRIBED ABOVE. THIS IS COMPLAINT 1 OF 4. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO THE SUPPLIER, TELEFLEX LLC. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF (B)(4)." THIS MDR REPRESENTS ONE OF THE FOUR INSTANCES DESCRIBED ABOVE. THIS IS COMPLAINT 1 OF 4. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO THE SUPPLIER, (B)(4). A SAMPLE FROM THE SAME LOT WAS RETURNED TO DEROYAL ON 1/31/2024 AND SHIPPED TO (B)(4) FOR TESTING. TELEFLEX PERFORMED BIOCOMPATIBILITY TESTING PER ISO 10993-17 ON THE RETURNED SAMPLE FROM THE SAME LOT. ALL BIOCOMPATIBILITY TESTING PASSED, AND NO DEFECTS WERE FOUND. DEROYAL INDUSTRIES REVIEWED PURCHASE ORDERS AND CORRECTIVE AND PREVENTIVE ACTIONS RELEVANT TO THIS INFORMATION AND NO ISSUES WERE IDENTIFIED. A COMPLAINT TO SALES RATIO WAS CALCULATED FROM (B)(6) 2021 TO (B)(6) 2023 AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE NO MANUFACTURING ISSUES COULD BE FOUND AND BIOCOMPATIBILITY TESTING PASSED, NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205254 SKIN STAPLER 35W STAPLER, SKIN QQS TELEFLEX LLC 25-3001 73B2300556 50749756024377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other