BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9763351 · Received February 27, 2020

    Report

    Report Number
    1645337-2020-03187
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 10, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, MENTOR BECAME AWARE OF THE FOLLOWING: LEFT IMPLANT ¿ CATALOG# 3501640 ¿ SERIAL #/ LOT# 6488549 RIGHT IMPLANT OR DEVICE B ¿ CATALOG# 3501640 ¿ SERIAL #/ LOT# 6833018 HENCE, THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 19, 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING VISUAL EXAMINATION OF THE DEVICE, A TEAR WAS OBSERVED ON THE POSTERIOR ASPECT AND EXTENDING TO ANTERIOR VIEW, MEASURING APPROXIMATELY 3.0 CM. MICROSCOPIC EXAMINATION IN THE TEAR EDGES, REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/13/2020, MENTOR BECAME AWARE THAT THE FOLLOW UP 2 REPORT STATED THAT ON 3/27/2020, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED. 3/27/2020 IS THE DATE OF INVESTIGATION COMPLETION NOT MANUFACTURING RECORD EVALUATION COMPLETION DATE. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 3/27/2020, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. AFTER MULTIPLE FOLLOW UPS FOR ADDITIONAL INFORMATION, THE REPORTED DATE OF IMPLANT ((B)(6) 2007) CAN¿T BE CONFIRMED, SINCE IT¿S BEFORE THE MANUFACTURING DATE OF THE DEVICES. IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON 3/2/2020, REPLACEMENT INFORMATION BELOW WAS PROVIDED BUT WAS INADVERTENTLY NOT REPORTED IN THE PREVIOUS SUBMISSION: LEFT: CATALOG NUMBER: 3501640; SERIAL NUMBER: (B)(6); RIGHT: CATALOG NUMBER: 3501635; SERIAL NUMBER: (B)(6). THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. 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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR ONE OF THE TWO IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226320 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501640 6833018 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention