MAUDE Adverse Event Report: TUBAL LIGATION CLAMPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fainting (1847); Hair Loss (1877); Pain (1994); Dizziness (2194); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 10/01/2011

Event Type  Injury  

Event Description

I had a tubal ligation done in 2010; worst mistake ever, i¿ve not been the same, severe weight gain, bad acne, severe abdominal and ovary pain, hair loss, severe depression, suicidal thought, emotional, severe anxiety, heavy periods that consists of severe pain, bloating, constantly dizzy and feeling faint.Fda safety report id # (b)(4).

• Brand Name: TUBAL LIGATION CLAMPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 8650657
• MDR Text Key: 146398080
• Report Number: MW5086958
• 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: 05/24/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BC POWDER; GOODY'S; IBUPROFEN; PROZAC 40 MG ONCE A DAY; TYLENOL; XANAX 1MG WHEN NEEDED
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 106