BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1818910-2019-100501

    MDR report key: 8874263 · Received August 8, 2019

    Report

    Report Number
    1818910-2019-100501
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 28, 2018
    Report Date
    July 1, 2019
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. INVESTIGATION SUMMARY: THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA (B)(4) SUPERSEDED BY MDD CAPA-(B)(4).

    Description of Event or Problem · 1

    ASR CLAIM LETTER ((B)(4)) RECORDS RECEIVED. AWAITING FOR ENGLISH TRANSLATION. ONCE TRANSLATION IS AVAILABLE, THIS COMPLAINT WILL BE UPDATED.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention