MAUDE Adverse Event Report: FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Patient Problems Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Menstrual Irregularities (1959); Anxiety (2328); Depression (2361); Abdominal Cramps (2543); Weight Changes (2607)

Event Date 01/01/2019

Event Type  Injury  

Event Description

I have several health issues such as severe cramps and heavy periods, cyst that i had surgically removed which came back, constant infections, weight gain, severe acne, loss of hair, migraines, random stomach cramps, fatigue, depression, anxiety all of this started after procedure was done.I was perfectly healthy prior and my doctor who's on the patients side with this one said so many horrible side effects come with such a procedure.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 17636694
• MDR Text Key: 322216529
• Report Number: MW5145012
• 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: 08/23/2023

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: 08/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic