BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8349267 · Received February 19, 2019

    Report

    Report Number
    2951250-2019-00730
    Event Type
    Injury
    Date Received
    February 19, 2019
    Report Date
    May 23, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5083551) ON 15-FEB-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-MAY-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ONE COIL LOST'), ABDOMINAL PAIN LOWER ('CRAMPING'), NEPHROLITHIASIS ('KIDNEY STONE') AND MYALGIA ('MUSCLE ACHES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), METHADONE AND TIZANIDINE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERION DISABILITY), NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("STOMACH SWELLING UP TO LOOKING LIKE 9 MONTH PREGNANT/SYMPTOMS OF PREGNANCY"), FEELING ABNORMAL ("FEELING MY ORGAN MOVING AROUND"), MENOPAUSE ("PREMENOPAUSAL"), ALOPECIA ("LOSS OF HAIR"), DYSGEUSIA ("METALLIC TASTE"), AMENORRHOEA ("NO MENSES"), MENSTRUATION IRREGULAR ("MENSTRUATION IRREGULAR"), STRESS ("STRESS"), DEPRESSION ("DEPRESSION"), FEAR ("FEAR"), MYALGIA (SERIOUSNESS CRITERION DISABILITY), MENTAL DISTRESS ("MENTAL PAIN AND SUFFERING/ MENTALITY PROBLEM"), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), TOOTH LOSS ("LOSS OF TEETH"), HEADACHE ("HEADACHES"), HAIR COLOUR CHANGES ("HAIR AND GRAY"), CONSTIPATION ("CONSTIPATING") AND EMOTIONAL DISTRESS ("HUMILIATING AND EMBARASSING"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN LOWER, NEPHROLITHIASIS, ABDOMINAL DISTENSION, FEELING ABNORMAL, MENOPAUSE, ALOPECIA, DYSGEUSIA, AMENORRHOEA, MENSTRUATION IRREGULAR, STRESS, DEPRESSION, FEAR, MYALGIA, MENTAL DISTRESS, ABNORMAL WEIGHT GAIN, TOOTH LOSS, HEADACHE, HAIR COLOUR CHANGES, CONSTIPATION AND EMOTIONAL DISTRESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ABNORMAL WEIGHT GAIN, ALOPECIA, AMENORRHOEA, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, FEAR, FEELING ABNORMAL, HAIR COLOUR CHANGES, HEADACHE, MENOPAUSE, MENSTRUATION IRREGULAR, MENTAL DISTRESS, MYALGIA, NEPHROLITHIASIS, STRESS, TOOTH LOSS AND EMOTIONAL DISTRESS WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE CONDUCTED A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5083551) ON 15-FEB-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE COIL LOST"), ABDOMINAL PAIN LOWER ("CRAMPING"), NEPHROLITHIASIS ("KIDNEY STONE") AND MYALGIA ("MUSCLE ACHES") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), METHADONE AND TIZANIDINE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERION DISABILITY), NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("STOMACH SWELLING UP TO LOOKING LIKE (B)(6) PREGNANT/SYMPTOMS OF PREGNANCY"), FEELING ABNORMAL ("FEELING MY ORGAN MOVING AROUND"), MENOPAUSE ("PREMENOPAUSAL"), ALOPECIA ("LOSS OF HAIR"), DYSGEUSIA ("METALLIC TASTE"), AMENORRHOEA ("NO MENSES"), MENSTRUATION IRREGULAR ("MENSTRUATION IRREGULAR"), STRESS ("STRESS"), DEPRESSION ("DEPRESSION"), FEAR ("FEAR"), MYALGIA (SERIOUSNESS CRITERION DISABILITY), MENTAL DISORDER ("MENTAL PAIN AND SUFFERING/ MENTALITY PROBLEM"), TOOTH LOSS ("LOSS OF TEETH"), HEADACHE ("HEADACHES"), HAIR COLOUR CHANGES ("HAIR AND GRAY"), CONSTIPATION ("CONSTIPATING") AND EMOTIONAL DISTRESS ("HUMILIATING AND EMBARRASSING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("EXCESSIVE WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN LOWER, NEPHROLITHIASIS, ABDOMINAL DISTENSION, FEELING ABNORMAL, MENOPAUSE, ALOPECIA, DYSGEUSIA, AMENORRHOEA, MENSTRUATION IRREGULAR, STRESS, DEPRESSION, FEAR, MYALGIA, MENTAL DISORDER, WEIGHT INCREASED, TOOTH LOSS, HEADACHE, HAIR COLOUR CHANGES, CONSTIPATION AND EMOTIONAL DISTRESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, AMENORRHOEA, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, EMOTIONAL DISTRESS, FEAR, FEELING ABNORMAL, HAIR COLOUR CHANGES, HEADACHE, MENOPAUSE, MENSTRUATION IRREGULAR, MENTAL DISORDER, MYALGIA, NEPHROLITHIASIS, STRESS, TOOTH LOSS AND WEIGHT INCREASED WITH ESSURE. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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
    143405 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other METHADONE| METHADONE| PROZAC| PROZAC| TIZANIDINE| TIZANIDINE| VICODIN| VICODIN| XANAX| XANAX| METHADONE| PROZAC| TIZANIDINE| VICODIN| XANAX