BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 19177116 · Received April 24, 2024

    Report

    Report Number
    3000219639-2024-00039
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 20, 2024
    Report Date
    June 24, 2024
    Manufacturer
    SALTER LABS
    Product Code
    BZD
    UDI-DI
    10607411007160
    PMA / PMN Number
    K143700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF: PRODUCT EXTREMELY RIGID. CAUSING SKIN BREAKDOWN. ALL INFORMATION REASONABLY KNOWN AS OF 24 APR 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE DATABASE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5; H1; ADDITIONAL INFORMATION: THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED IMAGES OF THE ALLEGED DEVICE. REVIEW OF THE IMAGES DID NOT CONFIRM THE REPORTED EVENT. WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION, THE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE. ALL INFORMATION REASONABLY KNOWN AS OF 28 JUN 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    PRODUCT EXTREMELY RIGID. CAUSING SKIN BREAKDOWN.

    Description of Event or Problem · 0

    PRODUCT EXTREMELY RIGID. CAUSING SKIN BREAKDOWN. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENTS' CONDITION OR CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584584 SALTER LABS CANNULAIDE SIZE 2, FOR BABIES 1250G-2000G, BZD SALTER LABS CA102-0-25 45205-1-1 10607411007160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other