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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Depression (2361)

Event Date 07/01/2014

Event Type  Injury  

Event Description

I had filshie clips placed on my tubes at the age of (b)(6).I am now (b)(6) and i am still in pain.I have been reporting my symptoms to different doctors over the years, and either i get blown off or doctors tell me it's all in my head.I live with very pain periods, sharp, intense stabbing pain in my tubes, extremely nauseous, heavy bleeding, depression, chronic or extreme fatigue and the list goes on.I don't want no doctor to reverse my tubes.I just want these clips off.I am tired of being in pain.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: 12829596
• MDR Text Key: 280960163
• Report Number: MW5105387
• 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: 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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: AMLODIPINE; LOSARTAN ; OZEMPIC
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American