BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12030407 · Received June 20, 2021

    Report

    Report Number
    3004932373-2021-00292
    Event Type
    Injury
    Date Received
    June 20, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 8, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY VANZI V, AN AUTHOR IN THE LITERATURE REVIEW ARTICLE TITLED J. WOUND CARE. PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE LITERATURE ARTICLE THAT THE INFANT EXPERIENCED A BURN ON THE SKIN AFTER CHG WAS USED. PER ARTICLE: BACKGROUND AND AIMS: PRESERVING SKIN INTEGRITY IN PRETERM INFANTS IS VITAL IN THE PREVENTION OF SEPSIS, EXCESSIVE WATER LOSS AND HYPOTHERMIA AND AT THE SAME TIME, AN EFFECTIVE ANTISEPSIS PRIOR TO INVASIVE PROCEDURES IS AN ESSENTIAL STEP TO TAKE CARE OF THESE VULNERABLE PATIENTS. EVEN IF CHLORHEXIDINE GLUCONATE (CHG) IS FREQUENTLY USED IN NICU , IN LITERATURE, THERE ARE SOME REPORTS OF CHG-RELATED SKIN INJURIES. METHODS: A CASE OF AN INFANT BORN AT 26 WEEKS GESTATION WHO SUSTAINED EXTENSIVE ABDOMINAL BURNS AFTER THE USE OF A CHG-SKIN PREPARATION APPLIED DURING THE INSERTION OF UMBILICAL CATHETER IS REPORTED. THESE INJURIES COMPLETELY HEALED WITH CONSERVATIVE MANAGEMENT OVER 4 WEEKS WITH NO RESIDUAL SCARRING. A REVIEW OF LITERATURE WAS UNDERTAKEN, IN ORDER TO EVALUATE THE SAFETY OF CHG IN INFANTS BORN UNDER 32 WEEKS GESTATION OR VLBW OR ELBW INFANTS. RESULTS: NO RANDOMIZED CONTROLLED TRIALS WERE FOUND. 7 PAPERS MET THE INCLUSION CRITERIA EXACTLY BECAUSE CONTAINED DATA FROM EARLY PREMATURE INFANTS, TREATED FOR SKIN ANTISEPSIS WITH CHG IN DIFFERENT PERCENTAGES IN BOTH AQUEOUS AND ALCOHOLIC SOLUTION. APPLICATION OF CHG SOLUTIONS CAN LEAD TO SERIOUS SKIN COMPLICATIONS, SUCH AS ERYTHEMA, EROSION AND BURN AND IT SHOULD BE USED WITH EXTREME CAUTION IN EARLY PRETERM INFANTS. CONCLUSIONS: ANTISEPTIC SOLUTIONS ARE COMMONLY USED FOR SKIN CARE BUT ARE NOT ALWAYS SAFE IN PRETERM INFANTS. CHG HAS SHOWN EXCELLENT STERILIZING CAPABILITIES BUT FURTHER STUDIES ARE NEEDED TO EVALUATE THE CLINICAL SKIN SAFETY OF CHG IN PREMATURE INFANTS. HEALTHCARE PROFESSIONALS SHOULD CONTINUE TO REPORT ANY SUSPECTED ADVERSE REACTIONS TO CHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927127 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other