BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRUM DESIGNS MEDICAL PECTORAL 1 (AIACHE)

    MDR report key: 1734280 · Received June 23, 2010

    Report

    Report Number
    2028306-2010-00001
    Event Type
    Other
    Date Received
    June 23, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 11, 2010
    Manufacturer
    SPECTRUM DESIGNS MEDICAL, INC.
    Product Code
    MIC
    PMA / PMN Number
    K944163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, (3) OF THE REPLACEMENT IMPLANTS WERE RETURNED TO SDM AND THE IMPLANT 550-621RT ((B)(4)) LOT 32472 WAS RETAINED BY THE PHYSICIAN, AND IMPLANTED INTO THE PATIENT. THE LEFT ORIGINAL IMPLANT WAS NOT EXPLANTED FROM THE PATIENT BECAUSE THE PATIENT WAS HAPPY WITH THE SIZE AND SHAPE OF IT, AND WANTED THE RIGHT IMPLANT TO MATCH THE LEFT. THE RIGHT EXPLANTED DEVICE 550-611RT FROM THE ORIGINAL SURGERY DID HAVE A MOLD MARK THAT THE PHYSICIAN CONFIRMED WITH SDM TO MATCH THE CORRECT CATALOG PART NUMBER THAT IT WAS LABELED AS. BECAUSE THE LEFT WAS NOT EXPLANTED AND RETURNED TO SDM, NO FURTHER INVESTIGATION CAN BE PERFORMED. SDM CAN ONLY CONCLUDE THAT THE COMPLAINT WAS NOT DUE TO MISLABELED PRODUCT, BUT RATHER PATIENT ASYMMETRY THAT WAS NOT IDENTIFIED PRIOR TO THE ORIGINAL SURGERY BY THE PHYSICIAN. BATCH RECORDS, LABEL RECORDS, STERILIZATION RECORDS, AND MOLD MARKS WERE ALL REVIEWED AS RELATED TO THIS COMPLAINT. NO INCONSISTENCIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT COMPLAINT OF ASYMMETRY 7 MONTHS AFTER INITIAL SURGERY FOR SOLID SILICONE PECTORAL IMPLANTS. PHYSICIAN NOTICED SOME ASYMMETRY DIRECTLY AFTER SURGERY, BUT ATTRIBUTED IT TO SWELLING. PATIENT LIKED THE SIZING OF THE LEFT IMPLANT, AND WANTED THE RIGHT TO MATCH THE LEFT. ORIGINAL IMPLANTS SENT TO DR. FOR THIS PATIENT'S SURGERY WERE A PAIR PECTORALS THE SAME SIZE. PHYSICIAN REPORTED NO SIGNS OF ASYMMETRY BEFORE SURGERY. SPECTRUM SENT REPLACEMENT IMPLANTS TO PHYSICIAN FOR EXPLANT/RE-IMPLANTATION. PT RECEIVED A NEW LARGER SIZED IMPLANT FOR THE RIGHT SIDE 550-621RT TO MATCH THE LEFT 550-611LT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM DESIGNS MEDICAL PECTORAL 1 (AIACHE) SOLID SILICONE PECTORAL IMPLANT, STERILE MIC SPECTRUM DESIGNS MEDICAL, INC. 550-611RT/550-611LT 32747/32483

    Patients

    Seq Age Sex Outcome Treatment
    1 Other