MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("sometime pain on right side") in an adult female patient who had essure inserted.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.Essure was removed on (b)(6)2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), headache ("headache"), dyspareunia ("pain during intercourses") and alopecia ("hair thinning").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).The reporter considered alopecia, dyspareunia, headache and pelvic pain to be related to essure administration.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 02-may-2023: reporter lawyer added, reference section, non drug treatment updated.Case category updated to serious incident.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 ("sometime pain on right side") in an adult female patient who had essure inserted (lot no.C28871 and cs000w6) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of vulvovaginitis, vaginal yeast, parity 5, multi gravida and vaginal itching in 2016.On (b)(6) 2015, the patient had essure inserted.At an unknown time, she experienced pelvic pain (seriousness criterion intervention required), headache ("headache"), dyspareunia ("pain during intercourses") and alopecia ("hair thinning").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2021.The reporter considered alopecia, dyspareunia, headache and pelvic pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2016: history: fallopian tubs inserts.Findings: the uterine cavity was filled with contrast with no internal defects or abnormalities, bliateral inserts are seen within the proximal fallopian tubes.Ne contrast le seen within the diste! fallopian tubes.Thare is no spillage of contrast inte the paritonaum bilaterally.Impression: sucecesend hystervealpingagrarn with no.Spillage of contrast inte the peritoneum.The most recent follow-up information incorporated above includes data received on: 22-sep-2023: reporter and patient information, medical history, lab data, indication, lot no., drug stop date, event onset date added.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.

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 ("sometime pain on right side") in an adult female patient who had essure inserted (lot no.C28871 , cs000w6 -invalid) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of vulvovaginitis, vaginal yeast, parity 5, multi gravida and vaginal itching in 2016.On (b)(6) 2015, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), headache ("headache"), dyspareunia ("pain during intercourses") and alopecia ("hair thinning").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).The reporter considered alopecia, dyspareunia, headache and pelvic pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [hysterosalpingogram] on (b)(6) 2016: history: fallopian tubs inserts.Findings: the uterine cavity was filled with contrast with no internal defects or abnormalities, bliateral inserts are seen within the proximal fallopian tubes.Ne contrast le seen within the diste! fallopian tubes.Thare is no spillage of contrast inte the paritonaum bilaterally.Impression: success hysterosalpingogram with no.Spillage of contrast into the peritoneum.Lot numbers reported ¿cs000w6¿ and ¿c28871¿ are invalid.Quality-safety evaluation of ptc: for essure: 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 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 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: 09-nov-2023: quality safety evaluation of ptc.An invalid lot number was received in this case.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17016945
• MDR Text Key: 316118068
• Report Number: 2951250-2023-02566
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: C28871 , CS000W6 -INVALID
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female