BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOC BAND

    MDR report key: 11032959 · Received December 17, 2020

    Report

    Report Number
    2030829-2020-00001
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    August 20, 2020
    Report Date
    November 30, 2020
    Manufacturer
    CRANIAL TECHNOLOGIES, INC.
    Product Code
    OAN
    UDI-DI
    B288CRANIALHELMET0
    PMA / PMN Number
    K014012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. REVIEW OF THE PROVISION OF TREATMENT CONFIRMED THAT ALL STANDARD CLINICAL PROCEDURES WERE FOLLOWED. PARENTS HAD ROUTINE QUESTIONS THROUGHOUT TREATMENT, WITH THESE QUESTIONS/CONCERNS BEING ADDRESSED AT EACH VISIT. THE DEVICE DOES APPEAR TO HAVE BEEN TAKEN OFF MORE FREQUENTLY THAN ADVISED. NO ONE WITNESSED THE EVENT THAT LED TO THE INJURY AND THE TIMELINE OF THE INJURY IS UNCERTAIN, SO NO DETERMINATION HAS BEEN MADE AT THIS POINT AS TO WHETHER, OR WHAT ROLE, THE DEVICE PLAYED IN THE REPORTED INJURY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    HEALTHY PATIENT (MINOR) WAS IN TREATMENT WITH CRANIAL ORTHOSIS FOR 3 MONTHS. DURING THE TREATMENT PERIOD, BABY SUFFERED AN INJURY TO THE NOSE CAUSING A BLOOD CLOT (SEPTAL HEMATOMA) REQUIRING SURGERY. MOM DISCLOSED DURING THE NEXT APPOINTMENT THAT BABY HAD SURGERY TO ADDRESS THE INJURY ON (B)(6) 2020. DURING THIS APPOINTMENT, AN ADJUSTMENT WAS MADE TO THE FRONT OF THE BAND TO KEEP IT FROM IRRITATING THE SURGICAL AREA. PATIENT HAD TWO WEEKS OF TREATMENT LEFT AT THIS POINT, BUT PARENTS CANCELED THE EXIT APPOINTMENT. ALMOST 5 WEEKS LATER, PARENTS SCHEDULED AND CAME IN FOR AN EXIT APPOINTMENT ON (B)(6) 2020. DURING THIS APPOINTMENT, PARENTS REPORTED THAT THE BABY HAD BROKEN HIS NOSE AND HAD A SEPTAL HEMATOMA (RATHER THAN WHAT WAS INITIALLY REPORTED AS A BLOOD CLOT). THOUGH THEY (PARENTS) DID NOT SEE THE INJURY OCCUR, THEIR ENT FELT THAT THE BAND CAUSED THE INJURY. SINCE THE INJURY/EVENT WAS NOT OBSERVED, AND NO INJURY WAS EXTERNALLY NOTICEABLE OR IDENTIFIED FOR SEVERAL DAYS, IT IS NOT CLEAR EXACTLY WHEN THE INJURY OCCURRED. AS A RESULT, IT IS NOT CLEAR AT THIS POINT WHETHER THE CRANIAL ORTHOSIS WAS INVOLVED IN CAUSING THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495633 DOC BAND CRANIAL ORTHOSIS OAN CRANIAL TECHNOLOGIES, INC. N/A 00244080 B288CRANIALHELMET0

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention