BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 7478477 · Received May 1, 2018

    Report

    Report Number
    1645337-2018-02558
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 9, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001713
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/12/2018 AND RECEIVED UPDATED INFORMATION ABOUT THE IDENTITY OF THE REPORTED DEVICE: BRAND NAME: MENTOR MEMORYSHAPE BREAST IMPLANT, PROCODE: FTR, COMMON DEVICE NAME: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED, CATALOG: 3341055, LOT: 7515245, SERIAL: (B)(4), UNIQUE IDENTIFIER (UDI): (B)(4), PMA/ 510(K): P060028. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE COMPLAINT DEVICE WAS A MENTOR LEIDEN BREAST IMPANT, BUT WAS MISTAKENLY RETURNED TO MENTOR. THE MENTOR LEIDEN BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT APPEAR TO MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS ASRS/PSRS OR MDRS. AS A RESULT, NO FURTHER ANALYSIS WILL TAKE PLACE. HOWEVER, SINCE THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, ANY ADDITIONAL INFORMATION WILL CONTINUE TO BE REPORTED AS APPLICABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 6/18/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED AT MENTOR CONTAINING A CLEAR GEL. DURING INITIAL EVALUATION A RENT WAS OBSERVED ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 9.7 CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE OBSERVED. COMPLAINT WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT RENTS ARE SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. THE DEVICE HISTORY RECORD ( DHR) OF LOT NUMBER 7515245 REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 8/3/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4),

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 125CC SALINE PROSTHESIS. RUPTURE ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED INTRA-OPERATIVELY THROUGH A VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MEMORYSHAPE BREAST IMPLANT 225CC GEL PROSTHESIS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319755 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7515245 00081317001713

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention