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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Intermenstrual Bleeding (2665); Cancer (3262)

Event Date 11/25/2011

Event Type  Injury  

Event Description

I had my tubes tied with filshie clips (b)(6) 2008 shortly after that a mass started growing in my lower abdomen and groin and i had to go through chemotherapy for it to go away the mass became cancerous and i still get pain, heavy menstrual flow and bleed in between menstruation due to having these filshie clip's.I need someone to contact me about this issue (b)(6), my name is (b)(6).Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12975945
• MDR Text Key: 282188093
• Report Number: MW5105958
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White