MAUDE Adverse Event Report: HOLOGIC, INC. ADIANA; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Abscess (1690); Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Convulsion/Seizure (4406); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

I have adiana.My gynecologist told me that was not the source of the reversed splinters that felt like i seat on fiberglass and i had small pieces poking out of the skin on my clitoris and continue to splinter and infect my whole body also causes me to have migraines and seizures, we know what else my families ever had cancers.I lost my hair in 2015.I started having arthritis symptoms, fatigue, memory losses, then i started having seizures, i had blackouts, pieces removed from my chin abscess, i've had four surgeries due to adiana and finally had them removed.I could not get any help and my gynecologist to install them with no help either he had other patients that migrated so i think he did not want me to report before then as being.No one believes what it was, so i was even "baker" acted everyone thought i was seeing things.I couldn't get anyone to help me and doctors were telling me that's not what it was.I could feel it inside of me is it moved to the uterus.It was not supposed to be dangling down.I lived with this problem of the migrating 80 on a birth control device for over four years because no one believes me, it has scarred my life and my face and my entire body i just got them out a couple of months ago, but they're still pieces floating around and coming out.I was wondering if there's anyway i could have them tested pieces that i have saved, so they can prove that it is what i said it was.Fda safety report id# (b)(4).

• Brand Name: ADIANA
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 14357742
• MDR Text Key: 291490266
• Report Number: MW5109621
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2022
• Patient Sequence Number: 1
• Treatment: THYROID MED
• Patient Outcome(s): Hospitalization; Life Threatening; Disability; Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: American Indian Or Alaskan Native