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

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Ambulation Difficulties (2544); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687)

Event Date 12/07/2011

Event Type  Injury  

Event Description

I requested sterilization and had filshie clips placed inside of me without my knowledge.I was not informed that they were inside of my body, therefore i was not informed that they would migrate through my body.The clips caused extreme pain which led to frequent er visits for pelvic pains.I have had vaginal bleeding without cause.My menstrual cycle was negatively affected.I am not able to walk during the first 2 days of my cycle.I had passed out from the pain and have been prescribed pain meds to combat the pain.I paid to have them removed but they could not find them.I visited an er where an x-ray was performed and they were able to locate the clips in my lower left pelvic area.They have fused into my flesh.I have a medical record file that is over 1000 pages because of the many er visits.I have migraines, i taste metal periodically, and have had seizers.I need you guys at the fda to understand that there is a large population of women being negatively affected by these clips.I am apart of a group on (b)(6) of more than 1000 women who are fighting to get these off of the market before someone dies.Our (b)(6) page is (b)(6).Please save a life and remove these from the market.We have set up a petition on (b)(6).We are fighting for our lives.Please save us, please.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: 10453810
• MDR Text Key: 204625307
• Report Number: MW5096268
• 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: 08/23/2020

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: 08/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR
• Patient Weight: 61