BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10020070 · Received May 4, 2020

    Report

    Report Number
    2951250-2020-06607
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    April 6, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 05-APR-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('ALLERGIC TO NICKEL') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508836) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PRURITUS AND URTICARIA, ARTHRALGIA ("JOINT PAIN THAT SUBSIDES SPONTANEOUSLY"), FATIGUE ("TIREDNESS"), ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS WITHRAWN). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FATIGUE, ABDOMINAL PAIN LOWER AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE (ESS205). LOT NUMBER: 508836 MANUFACTURING DATE: 2005-09 EXPIRATION DATE: 2007-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-APR-2021: HA NUMBER RE-SENT. NO NEW INFORMATION RECEIVED, UPDATE TO IMDRF/FDA CODES ONLY. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-MAY-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('ALLERGIC TO NICKEL') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508836) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PRURITUS AND URTICARIA, ARTHRALGIA ("JOINT PAIN THAT SUBSIDES SPONTANEOUSLY"), FATIGUE ("TIREDNESS"), ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS WITHRAWN). ESSURE (ESS205) WAS REMOVED ON (B)(6)2020. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FATIGUE, ABDOMINAL PAIN LOWER AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. LOT NUMBER: 508836 MANUFACTURING DATE: 2005-09 EXPIRATION DATE: 2007-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2020: INSERTION DATE ADDED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-MAY-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('ALLERGIC TO NICKEL') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508836) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PRURITUS AND URTICARIA, ARTHRALGIA ("JOINT PAIN THAT SUBSIDES SPONTANEOUSLY"), FATIGUE ("TIREDNESS"), ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS WITHDRAWN). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FATIGUE, ABDOMINAL PAIN LOWER AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE (ESS205). LOT NUMBER: 508836, MANUFACTURING DATE: 2005-09, EXPIRATION DATE: 2007-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAY-2020: QUALITY SAFETY EVALUATION OF PTC. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 29-APR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('ALLERGIC TO NICKEL') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508836) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PRURITUS AND URTICARIA, ARTHRALGIA ("JOINT PAIN THAT SUBSIDES SPONTANEOUSLY"), FATIGUE ("TIREDNESS"), ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS WITHDRAWN). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FATIGUE, ABDOMINAL PAIN LOWER AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE (ESS205). 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
    483756 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 508836 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R