BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH 4151

    MDR report key: 5729784 · Received June 16, 2016

    Report

    Report Number
    2648988-2016-00029
    Event Type
    Injury
    Date Received
    June 16, 2016
    Report Date
    May 31, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JULY 1ST, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; NO SAMPLE WILL BE RETURNED FOR EVALUATION. NO PICTURES OF SKIN CONDITION WERE PROVIDED AND THEREFORE THE EVENT COULD NOT BE CONFIRMED. DHR REVIEW; THE FINISHED GOOD (FG) LOT #S 1151954 AND 1150573 WERE REVIEWED IN ORDER TO DETECT ANY ANOMALIES THAT COULD HAVE OCCURRED DURING THE PRODUCT MANUFACTURING PROCESS WHICH COULD HAVE CONTRIBUTED OR BE RELATED WITH THE REPORTED CONDITION BEING INVESTIGATED (BURN MARKS ON BABY). BOTH LOTS WERE RELEASED FOR DISTRIBUTION IN COMPLIANCE WITH THE PRODUCT SPECIFICATIONS AND INTEGRA REQUIREMENTS INCLUDING CHG POTENCY. NO ANOMALY OR DISCREPANCIES WERE REPORTED DURING THE MANUFACTURE OF THE FG LOT THAT COULD BE RELATED TO THE REPORTED CONDITION (BURN MARKS ON BABY). COMPLAINTS HISTORY; UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM JUNE 2014 - JUNE 2016, A TOTAL OF 25 COMPLAINTS (INCLUDING THE ONES UNDER EVALUATION) RELATED TO ADVERSE REACTION FOR BIOPATCH PRODUCT FAMILY. TEN (10) OF THESE 25 COMPLAINTS ARE RELATED TO CHILDREN OR BABIES, FOR WHICH SAFETY AND EFFECTIVENESS OF THE DEVICE HAS NOT BEEN ESTABLISHED AS INDICATED IN THE IFU. THE COMPLAINT DISTRIBUTION IS AS FOLLOWS: NINE (9) IN JUN-DEC 2014, NINE (9) IN 2015, AND SEVEN (7) IN JAN-JUN 2016. APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION SINCE JUNE 2014 - JUNE 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: THE REPORTED CONDITION ¿BURN MARKS¿ COULD NOT BE CONFIRMED SINCE PICTURES WERE NOT PROVIDED BY THE CUSTOMER. NO ASSIGNABLE CAUSE THAT COULD BE ASSOCIATED TO THE MANUFACTURING PROCESS OF BIOPATCH WAS IDENTIFIED. NO ANOMALIES WERE NOTICED IN EITHER OF THE DHRS REVIEWED. BIOPATCH¿S IFU LITERATURE RECOGNIZES THE POSSIBILITY OF AN ADVERSE REACTION: ¿ADVERSE REACTIONS TO CHLORHEXIDINE GLUCONATE SUCH AS DERMATITIS, HYPERSENSITIVITY, AND GENERALIZED ALLERGIC REACTIONS ARE VERY RARE, BUT IF ANY SUCH REACTIONS OCCUR, DISCONTINUE USE OF THE DRESSING IMMEDIATELY.¿ IT IS UNKNOWN THE BABIES¿ AGE, HEALTH CONDITION, HISTORY OF ALLERGIES, THE AMOUNT OF TIME UNDER TREATMENT, OR DRESSING CHANGE FREQUENCY. IFU CLEARLY WARNS THAT: ¿THE SAFETY AND EFFECTIVENESS OF BIOPATCH® HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 16 YEARS OF AGE.¿

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PATIENT 3 OF 3: IT WAS REPORTED BY SALES REPRESENTATIVE THAT AFTER PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE) PROCEDURE, BURN MARKS WERE OBSERVED IN SHAPE OF BIOPATCH ON A BABY. PRODUCT WILL NOT BE AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383917 BIOPATCH 4151 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1151954 OR 1150573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other