BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 8339657 · Received February 14, 2019

    Report

    Report Number
    9617229-2019-00975
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    December 16, 2018
    Report Date
    February 14, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: D. CASELLA, G. DI TARANTO AND M. MARCASCIANO ET AL., SUBCUTANEOUS EXPANDERS AND SYNTHETIC MESH FOR BREAST RECONSTRUCTION: LONG-TERM AND PATIENT-REPORTED BREAST-Q OUTCOMES OF A SINGLE-CENTER PROSPECTIVE STUDY, JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, HTTPS://DOI.ORG/10.1016/J.BJPS.2018.12.018. THE EVENTS OF NECROSIS, WOUND DEHISCENCE, AND CAPSULAR CONTRACTURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    JOURNAL ARTICLE TITLED "SUBCUTANEOUS EXPANDERS AND SYNTHETIC MESH FOR BREAST RECONSTRUCTION: LONG-TERM AND PATIENT-REPORTED BREAST-Q OUTCOMES OF A SINGLE-CENTER PROSPECTIVE STUDY" FROM THE 'JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY PP. 1-8' REPORTS: 16 POST OPERATIVE COMPLICATIONS THAT REQUIRED A SECOND OPERATION OCCURRED AS FOLLOWS: 2 SKIN-NIPPLE NECROSIS, 7 INFECTIONS, 4 WOUND DEHISCENCES, AND 3 SEROMAS, IN ADDITION TO 5 TUMOUR RECURRENCES, 9 CAPSULAR CONTRACTURES, 2 IMPLANT DYSTOPIAS AND 28 CASES OF RIPPLING. THIS RECORD REPRESENTS AN UNSPECIFIED QUANTITY OF DEVICES. THE DEVICES WERE IMPLANTED AS PART OF A RECONSTRUCTION. THE AFFECTED SIDE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133990 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention