BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10065243 · Received May 18, 2020

    Report

    Report Number
    2951250-2020-07814
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    January 1, 2011
    Report Date
    October 1, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LOWER BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50540028) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEELING ABNORMAL ("RUSHED FEELING") AND SKIN DISORDER ("SKIN PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), TINNITUS ("RINGING IN THE EARS"), HYPERVENTILATION ("HYPERVENTILATION"), PALPITATIONS ("PALPITATIONS"), AMNESIA ("MEMORY LOSS") AND FATIGUE ("CHRONICALLY TIRED") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED IN (B)(6) 2020. AT THE TIME OF THE REPORT, THE BACK PAIN, FEELING ABNORMAL, SKIN DISORDER, DIZZINESS, TINNITUS, HYPERVENTILATION, PALPITATIONS, AMNESIA, HORMONE LEVEL ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, BACK PAIN, DIZZINESS, FATIGUE, FEELING ABNORMAL, HORMONE LEVEL ABNORMAL, HYPERVENTILATION, PALPITATIONS, SKIN DISORDER AND TINNITUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SINCE THE REMOVAL SURGERY, HER HEALTH HAS IMPROVED. SHE HAS LESS BACK PAIN AND IS GRADUALLY FEELING MORE ENERGETIC. HER SYMPTOMS ARE DECREASING, BUT SHE IS NEGATIVELY ANTICIPATING A LONG RECOVERY FROM THE DAMAGE CAUSED BY THE ESSURE. LOT NUMBER: 50540028, MANUFACTURING DATE:2010-08, EXPIRATION DATE:2013-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2020: EVENTS LOWER BACK PAIN, RUSHED FEELING, SKIN PROBLEMS. DIZZINESS, RINGING IN THE EARS, HYPERVENTILATION, PALPITATIONS, MEMORY LOSS, HORMONAL PROBLEMS AND CHRONICALLY TIRED ADDED. ESSURE WAS REMOVED IN (B)(6) 2020. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN BODY MATERIAL WILL BE REMOVED ON 17-JUN-2020') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50540028) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE SCHEDULED). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 50540028 MANUFACTURING DATE:2010-08 EXPIRATION DATE:2013-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN BODY MATERIAL WILL BE REMOVED ON (B)(6) 2020') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 50540028) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE SCHEDULED). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2020: PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED TO MEDICAL DEVICE REMOVAL, CASE UPGRADED TO SERIOUS INCIDENT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531453 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 50540028 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R