Model Number ESS305 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problem
Pain (1994)
|
Event Date 08/01/2015 |
Event Type
Injury
|
Event Description
|
This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure inserted (lot no.C49142) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2015 she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal distension ("bloating"), headache ("headaches"), fungal infection ("yeast infections"), migraine ("migraines") and urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and was found to have weight increased ("weight gain").An unknown time later she experienced genital haemorrhage ("general abnormal bleeding"), intermenstrual bleeding ("metrorrhagia (bleeding between periods)"), menstruation irregular ("irregular period") and vaginal infection ("vaginal infection").The patient was treated with surgery (hysterectomy - uterus).Essure was removed on (b)(6) 2022.At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain, back pain, fungal infection, genital haemorrhage, headache, intermenstrual bleeding, menstruation irregular, migraine, pelvic pain, urinary tract infection, vaginal infection and weight increased to be related to essure administration.The reporter commented: discrepancy noted insertion date: 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.73 kg/sqm.[hysterosalpingogram] on (b)(6) 2015: essure confirmation test (unspecified) result unknown.Concerning the injuries reported in this case, the following were described in patient¿s medical records: pelvic pain, bloating.Batch no c49142; production date 2014-04-10; expiration date 2017-04-30.The most recent follow-up information incorporated above includes data received on: 02-may-2023: report from lawyer.Essure removal added.Event pelvic pain was upgraded to serious incident.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.
|
|
Manufacturer Narrative
|
This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure inserted (lot no.C49142) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2015, she experienced pelvic pain (seriousness criterion intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), abdominal distension ("bloating"), headache ("headaches"), fungal infection ("yeast infections"), migraine ("migraines") and urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: urinary tract") and was found to have weight increased ("weight gain").Essure was removed on (b)(6) 2022.An unknown time later she experienced genital haemorrhage ("general abnormal bleeding"), intermenstrual bleeding ("metrorrhagia (bleeding between periods)"), menstruation irregular ("irregular period") and vaginal infection ("vaginal infection").The patient was treated with surgery (hysterectomy - uterus).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain, back pain, fungal infection, genital haemorrhage, headache, intermenstrual bleeding, menstruation irregular, migraine, pelvic pain, urinary tract infection, vaginal infection and weight increased to be related to essure administration.The reporter commented: discrepancy noted insertion date: 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.73 kg/sqm.[hysterosalpingogram] on (b)(6) 2015: essure confirmation test (unspecified) result unknown.Concerning the injuries reported in this case, the following were described in patient¿s medical records : pelvic pain, bloating.Batch no: c49142.Production date: 2014-04-10.Expiration date: 2017-04-30.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are 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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 01-jun-2023: 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.
|
|
Search Alerts/Recalls
|
|