BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS KIT

    MDR report key: 7832479 · Received August 30, 2018

    Report

    Report Number
    2125050-2018-00644
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    August 31, 2016
    Report Date
    November 19, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. HOWEVER, BECAUSE QUALITY'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN, QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS. QUALITY REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO SIGNIFICANT TRENDS FOR LOT 4944763. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCE'S FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT. THIS COMPLAINT WAS FORWARDED TO THE CONTRACT MANUFACTURER (CM) FOR REVIEW. THE CM REVIEWED THE MANUFACTURING RECORDS FOR THIS DEVICE AND CONFIRMED THAT THERE WERE NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT AND VERIFIED THAT THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A (B)(6) PATIENT EXPERIENCED GROIN PAIN AFTER ALTIS PROCEDURE. DATE OF PROCEDURE: (B)(6) 2016, DATE OF ONSET EVENT: (B)(6) 2016. DESCRIPTION OF THE EVENT: PAIN DURING PHYSICAL ACTIVITIES (INTENSITY=7), INGUINAL PAIN AND IN THE LATERAL SIDE OF THE THIGH. TREATMENT: PARACETAMOL AND PREGABALIN 300MG STATUS OF THE EVENT: RESOLVED ON (B)(6) 2016 (DEVICE STILL IMPLANTED). ACCORDING THE INVESTIGATOR, THE EVENT IS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673715 ALTIS KIT SURGICAL MESH PAH COLOPLAST A/S 5196501022 4944763

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other