BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Dressing, wound, drug

    MDR report key: 12448842 · Received September 9, 2021

    Report

    Report Number
    9618003-2021-01985
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Report Date
    August 12, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: AQUACEL AG+ SCD DRS 9X10CM (1X10PK) US, COMMON DEVICE NAME : DRESSING, WOUND, DRUG, PRODUCT CODE: FRO, PMA /510(K) #: K091034. (B)(4). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. INVESTIGATION SUMMARY: BASED ON THE INFORMATION SUMMARIZED ABOVE, THE INVESTIGATION CONCLUDED THAT THE DIRECT CAUSE OF THE FAILURE WAS DURING INSTALLATION AND VALIDATION OF THE OFFTAKE ROLLER, THE ROLLER WAS NOT SET EFFECTIVELY TO ACCOUNT FOR OTHER LINE CONDITIONS DURING THE INSTALLATION AND VALIDATION, THIS IS TURN HAD THE POTENTIAL FOR FIBER BUILD UP AND THE ABILITY FOR THE EXCESS FIBER TO DROP ONTO THE FABRIC. THIS ISSUE HAS SINCE BEEN RECTIFIED AND SIGNIFICANTLY REDUCED THE RISK OF FURTHER ISSUES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AQUACEL SILVER PORTION OF THE DRESSING HAD DARKENED IN ONE SPOT AS IF IT HAD GOTTEN WET OR COME INTO CONTACT WITH SOME TYPE OF SUBSTANCE. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349000 Dressing, wound, drug FRO CONVATEC DOMINICAN REPUBLIC INC 422603 9L01169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown