BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FALLOPIAN TUBE OCCLUSION INSERT

    MDR report key: 22037787 · Received May 16, 2025

    Report

    Report Number
    2951250-2025-00334
    Event Type
    Injury
    Date Received
    May 16, 2025
    Report Date
    May 21, 2025
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4). PERFORATION OF ORGAN [PERFORATION OF ORGAN]. INSERTION DIFFICULT [DEVICE INSERTION DIFFICULT]. CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY AN INVESTIGATOR AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGAN") IN AN ADULT FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: JAY M. COOPER, MD, CHARLES S. CARIGNAN, MD, DANIEL CHER, MD, AND JOHN F. KERIN,. MICROINSERT NONINCISIONAL HYSTEROSCOPIC STERILIZATION. THE AMERICAN CORTEGE OF OBSTETRICLANS AND GYNECOLOGISTS. PUBLISHED BY ELSEVIER. 2000; 102: 67. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("INSERTION DIFFICULT"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE HYSTEROSCOPICALLY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. THE REPORTER CONSIDERED PERFORATION TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR FALLOPIAN TUBE OCCLUSION INSERT: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSIS OF COMPLAINTS IS REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 12-MAY-2025: NO NEW INFORMATION RECEIVED. LITERATURE ARTICLE RE-ATTACHED TO THE REPORT. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4) PERFORATION OF ORGAN [PERFORATION OF ORGAN], INSERTION DIFFICULT [DEVICE INSERTION DIFFICULT]. CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY AN INVESTIGATOR AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGAN") IN AN ADULT FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: JAY M. COOPER, MD, CHARLES S. CARIGNAN, MD, DANIEL CHER, MD, AND JOHN F. KERIN, MICROINSERT NONINCISIONAL HYSTEROSCOPIC STERILIZATION. THE AMERICAN CORTEGE OF OBSTETRICANS AND GYNECOLOGISTS. PUBLISHED BY ELSEVIER. 2000; 102: 67. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("INSERTION DIFFICULT"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE HYSTEROSCOPICALLY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. THE REPORTER CONSIDERED PERFORATION TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR FALLOPIAN TUBE OCCLUSION INSERT: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSIS OF COMPLAINTS IS REVIEWED REGULARLY; NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104124 FALLOPIAN TUBE OCCLUSION INSERT TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R