BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIPACK STERILE POLYESTER SPUN SWAB

    MDR report key: 16983354 · Received May 23, 2023

    Report

    Report Number
    3012642695-2023-00085
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 23, 2023
    Manufacturer
    STERIPACK USA (LIMITED) LLC
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: LUMIRADX INC. PURCHASE STERIPACK STERILE POLYESTER SPUN SWABS FOR SALE/DISTRIBUTION TO CUSTOMERS FOR USE IN PATIENT SAMPLE COLLECTION, FOR TESTING WITH LUMIRADX PRODUCTS. LUMIRADX RECEIVED A REPORT FROM A CUSTOMER ON (B)(6) 2023, IDENTIFYING THAT A STERIPACK STERILE POLYESTER SPUN SWAB BROKE WHEN ATTEMPTING TO COLLECT A NASAL SAMPLE FROM A PATIENT. THE REPORT WAS MADE VIA THE CUSTOMER ATTESTATION FORM ASSOCIATED WITH RECALL 3012642695-05/01/23-001-R. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED EVENT. EVENT DETAILS WERE REPORTED TO THE SWAB MANUFACTURER FOR INVESTIGATION. THE RECEIPT OF ANY NEW INFORMATION PERTAINING TO THIS EVENT WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SWAB BROKE WHEN ATTEMPTING TO COLLECT A PATIENT SAMPLE. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257605 STERIPACK STERILE POLYESTER SPUN SWAB STERIPACK STERILE POLYESTER SPUN SWAB KXG STERIPACK USA (LIMITED) LLC 60566 CARTON-85438

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown