BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 12668523 · Received October 20, 2021

    Report

    Report Number
    1645337-2021-11699
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITE WAS REVIEWED: SUNGMI JEON, JEONG HYUN HA, UNG SIK JIN DIRECT COMPARISON OF CGCRYODERM AND DERM ACELL IN THE SAME PATIENT FOR OUTCOMES IN BILATERAL IMPLANT-BASED BREAST RECONSTRUCTION: A RETROSPECTIVE CASE SERIES. PMID: 34422582, PMCID: PMC8340342, DOI: 10.21037/GS-21-149. THE ARTICLE FILE SIZE IS TOO LARGE TO ATTACH TO THIS REPORT, AND IT HAS THUS BEEN OMITTED FROM THE SUBMISSION. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITE WAS REVIEWED: SUNGMI JEON, JEONG HYUN HA, UNG SIK JIN DIRECT COMPARISON OF CGCRYODERM AND DERM ACELL IN THE SAME PATIENT FOR OUTCOMES IN BILATERAL IMPLANT-BASED BREAST RECONSTRUCTION: A RETROSPECTIVE CASE SERIES. PMID: 34422582, PMCID: PMC8340342, DOI: 10.21037/GS-21-149. OBJECTIVE AND METHODS: THE AIM OF THIS STUDY WAS TO COMPARE POSTOPERATIVE COMPLICATIONS BETWEEN CGCRYODERM AND DERMACELL. A RETROSPECTIVE CHART REVIEW WAS PERFORMED ON 32 PATIENTS (64 BREASTS) WHO UNDERWENT BILATERAL PROSTHETIC BREAST RECONSTRUCTION BETWEEN JUNE 2015 AND DECEMBER 2019. ALL PATIENTS RECEIVED TWO DIFFERENT ADMS IN EACH BREAST DURING THE SURGERY. DEMOGRAPHIC VARIABLES, OPERATIVE CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE COMPARED BETWEEN THE CRYOPRESERVED AND PRE-HYDRATED ADM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TE SILTEX®-TEXTURED MENTOR® CPX¿4 AND MENTOR®CPG4. OTHER MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE EXACT QUANTITIES OF PRODUCTS INVOLVED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BOTH STUDY GROUPS: QTY 9 OVERALL COMPLICATION . QTY 8 MAJOR COMPLICATIONS TREATED WITH REOPERATION (QTY 8 WERE IN TWO-STAGE GROUP) - NO FURTHER INFORMATION PROVIDED. QTY 3 SEROMAS (QTY 2 IN THE DERMACELL GROUP). QTY 5 INFECTIONS (QTY 4 IN THE DERMACELL GROUP). QTY 2 HEMATOMA (QTY 1 IN THE DERMACELL GROUP). QTY 3 MASTECTOMY FLAP NECROSIS (QTY 1 IN THE DERMACELL GROUP). A FOLLOW UP WAS PERFORMED AT THE TIME OF REVIEW AND THE AUTHOR PROVIDED ADDITIONAL INFORMATION ON 04-OCT-2021. CASE NUMBER 1 - LT IS A (B)(6) YEAR-OLD FEMALE PATIENT THAT EXPERIENCED MILD UPWARD DISPOSITION OF THE LEFT-SIDED BREAST IMPLANT. TREATMENT INFORMATION WAS NOT PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560943 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other