BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 133MV TISSUE EXPANDER

    MDR report key: 6145503 · Received December 5, 2016

    Report

    Report Number
    9617229-2016-00203
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    October 16, 2014
    Report Date
    December 5, 2016
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF INFECTION WAS PREVIOUSLY SUBMITTED VIA ASR ON 07/29/2016. THE EVENT OF INFECTION WAS ALSO PREVIOUSLY SUBMITTED VIA MEDWATCH MFR # 9617229-2016-00165 ON 11/02/2016. THIS MEDWATCH CONTAINS THE MOST RECENT INFORMATION REGARDING THIS CASE INCLUDING NEW REPORT OF DEVICE INFORMATION RECEIVED ON 11/10/2016. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE HISTORY REVIEW (DHR) SUMMARY: REVIEW OF DHR FOR WORK ORDER (B)(4) DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE EVENT. ALL TISSUE BREAST IMPLANTS WERE REVIEWED AS PART OF THE ASSEMBLY OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT ASSEMBLY MET THE REQUIRED SPECIFICATIONS. THE DHR ASSEMBLY REPORT FROM SAP WAS VERIFIED AND SEVEN DEVICES WERE SCRAPPED DURING THE ASSEMBLY PROCESS (7 OT ¿ 1 P8) WHICH IS NOT RELATED TO THE REPORTED EVENT. REVIEW OF STERILIZATION AND SEAL STRENGTH RECORDS RELATED TO WORK ORDER (B)(4) DID NOT IDENTIFIED ANY DEVIATIONS OR NON-CONFORMITIES THAT MAY BE ASSOCIATED WITH THE REPORTED DEVICE. STERILIZATION PROCESS WAS SUCCESSFULLY COMPLETED AND SEAL STRENGTH TEST RESULTS WERE FOUND TO BE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS FOR (B)(6) 2014 WERE REVIEWED AND ALL RESULTS WERE FOUND ACCEPTABLE. BIOBURDEN TESTING RESULTS FOR IQ 2014 WERE FOUND TO BE ACCEPTABLE. WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(4) WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN MEDICAL PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO (B)(4) MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. DEVICE LABELING: "DO NOT EXPOSE THE PRODUCT OR THE NEEDLE FOR PHYSIOLOGICAL SALINE INFUSION TO ANY CONTAMINATED OBJECT, IN VIEW OF POSSIBLE ELEVATION IN THE RISK FOR INFECTION." "IN PATIENTS HAVING ACTIVE INFECTION, IMPLANTATION OF THIS PRODUCT CAN ELEVATE THE RISK FOR INFECTION AROUND THE PRODUCT." "ALTHOUGH RARELY, ACUTE INFECTION MAY DEVELOP IN THE BREAST FOLLOWING INSERTION OF THE IMPLANT."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED RIGHT SIDE DEVICE REMOVAL AND REPLACEMENT DUE TO ¿INFECTION.¿ UPON FURTHER REVIEW, THIS EVENT WAS DETERMINED TO BE PART OF AN ELECTRONIC JOURNAL ARTICLE, REPORTED AS A PATIENT EXPERIENCING A ¿MINOR INFECTION OF THE TE.¿ THE ELECTRONIC JOURNAL ARTICLE WAS ¿AESTHETIC OUTCOMES OF INFRAMAMMARY FOLD RECREATION IN TWO-STAGE, IMPLANT-BASED, BREAST RECONSTRUCTION,¿ PUBLISHED IN SPRINGER OPEN, 16 SEPT. 2016, PP 1-6. THE AUTHORS STATED THAT ALL PATIENTS WERE IMPLANTED WITH ALLERGAN NATRELLE 133 TISSUE EXPANDERS THAT WERE REPLACED WITH ALLERGAN NATRELLE 410 DEVICES. TREATMENT FOR THE INFECTION WAS NOTED ON A SUBMITTED PRODUCT FIELD NOTE TO HAVE BEEN ¿EXCHANGING SBI.¿ THE TISSUE EXPANDER WAS EXPLANTED AND REPLACED WITH A NATRELLE 410 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796373 STYLE 133MV TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) 2568274

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention