BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX MEDIUM HEIGHT TISSUE EXPANDER STYLE 9200, 800CC

    MDR report key: 7253124 · Received February 8, 2018

    Report

    Report Number
    1645337-2018-00738
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    June 30, 2016
    Report Date
    January 25, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR ON 03/02/2018. PATIENT #7 USED MENTOR DEVICE WITH CATALOG 354-9216, LOT 6973270. DATE OF INFECTION WAS (B)(6) 2015. INFECTION WAS PROCEDURE RELATED, WITH NO BODY IMPAIRMENT INVOLVEMENT. PATIENT REQUIRED HOSPITALIZATION, SURGERY, ANTIBIOTICS AND FULLY RECOVERED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBERS 6973270 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REF.: (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER COMPANIES¿ DEVICE WERE USED IN THIS STUDY: STERILIZED ALLODERM ACELLULAR DERMAL MATRIX (LIFECELL). NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1 PATIENT IN THE POST INTERVENTION GROUP UNDERWENT BREAST RECONSTRUCTION SURGERY AND SUFFERED INFECTION RESULTING IN EXPLANTATION. INFECTIONS OCCURRED WITHIN THE FIRST 6 WEEKS FOLLOWING SURGERY. TITLE: ¿ABSORBABLE ANTIBIOTIC BEADS PROPHYLAXIS IN IMMEDIATE BREAST RECONSTRUCTION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF THIS PROTOCOL MODIFICATION ON PERIPROSTHETIC INFECTION RATES THAT RESULTED IN EXPLANTATION OF THE EXPANDER. THE STUDY WAS CONDUCTED FROM DEC 2012 TO JUNE 2016. A MENTOR BIODIMENSIONAL TEXTURED SURFACE EXPANDER WITH AN INTEGRATED VALVE WAS USED IN THIS PROCEDURE, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95252 SILTEX MEDIUM HEIGHT TISSUE EXPANDER STYLE 9200, 800CC EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6973270

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R