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

Device Problems Labelling, Instructions for Use or Training Problem (1318); Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Failure of Implant (1924); Menstrual Irregularities (1959); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 02/09/2021

Event Type  Injury  

Event Description

In (b)(6) of 2005 i had the filshie clamps placed (unknown ) by my dr.For 15 years i struggled with heavy periods blood clots.I was told it was normal.In (b)(6) 2021 i ended up having to have a full hysterectomy where the dr found that the filshie clamps had migrated from my fallopian tubes and had attached itself to my intestines and that if it had been left any longer could have caused my intestines to die and for me to become septic.These clamps was never explained to me because a dr decided to use them without explaining the side effects.These clamps are dangerous and should be taken off the market let alone be used to sterilize women.I had issue after issue including mental issues because titanium should never be placed inside the body.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLAMP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 13002151
• MDR Text Key: 282297403
• Report Number: MW5106021
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White