BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9292299 · Received November 7, 2019

    Report

    Report Number
    9617229-2019-18037
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Report Date
    January 31, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FI SUMMARY: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH WORK ORDER 3130858 WERE RELEASED IN ACCORDANCE WITH ALLERGAN¿S PROCEDURES, AND NO ANOMALIES WERE FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. DURING THE DEVICE ANALYSIS IT WAS OBSERVED A HARD PIECE OF PLASTIC WHICH IS RELATED TO THE REPORTED EVENT. IT¿S NOT CONSIDERED A WORKMANSHIP SINCE THE DEVICE WAS NOT RECEIVED IN THE ORIGINAL SEALED PACKAGING. AN INSPECTION IN THE PRIMARY PACKAGING OPERATION WAS PERFORMED TO OBTAIN SAMPLES OF MATERIALS SIMILAR TO THE FOREIGN MATERIAL RECEIVED IN THE DAL, HOWEVER, NONE MATCHED THE CHEMICAL COMPOSITION THAT THE FOREIGN MATERIAL HAS. CONSIDERING THAT THERE IS NOT AN ADVERSE TREND FOR THIS EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUES WITH FOREIGN MATERIAL ON IMPLANT WILL CONTINUE TO BE MONITORED AND A CORRECTIVE ACTION WILL TAKE IN THE FUTURE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED; "INSIDE THE PACKAGING THERE WAS A SHARP HARD PIECE OF PLASTIC AND THE IMPLANT". THE DEVICE HAS NOT BEEN IMPLANTED AND DID NOT TOUCH THE PATIENT.

    Additional Manufacturer Narrative · 1

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED; THE WEIGHT THE DEVICE WITHIN SPECIFICATION, CREASE FLAT AND DEFORMATION. AFTER AUTOCLAVE CYCLE: OBSERVED VOIDS. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: OBSERVED A HARD PIECE OF PLASTIC INSIDE A PLASTIC CONTAINER. IT IS NOT CONSIDERED A WORKMANSHIP SINCE THE PIECE OF PLASTIC WAS NOT RECEIVED IN THE ORIGINAL SEALED PACKAGING. HOWEVER, A FURTHER INVESTIGATION WILL BE REQUESTED TO ANALYZE THIS CASE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: OBSERVED WHAT APPEARS TO BE A HARD PIECE OF PLASTIC.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR RETURN: FOREIGN MATERIAL ON IMPLANT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED; "INSIDE THE PACKAGING THERE WAS A SHARP HARD PIECE OF PLASTIC AND THE IMPLANT". THE DEVICE HAS NOT BEEN IMPLANTED AND DID NOT TOUCH THE PATIENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED; "INSIDE THE PACKAGING THERE WAS A SHARP HARD PIECE OF PLASTIC AND THE IMPLANT". THE DEVICE HAS NOT BEEN IMPLANTED AND DID NOT TOUCH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085514 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3130858

    Patients

    Seq Age Sex Outcome Treatment
    1