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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Pregnancy with a Contraceptive Device (4517)

Event Date 02/03/2020

Event Type  Injury  

Event Description

Unwanted pregnancy; i was told that having the clips was the only option i had when getting my tubes tied after delivery.We had discussed it at my dr office for months and no other options were present.At the hospital, i stated again that i wanted them cut and was told the clips were permanent and i had nothing to worry about.On (b)(6) 2020, the day after delivery, the procedure with the filshie clips was done.After several failed attempts to properly place the needle and place the clips, i went to recover.I caught a severe infection that they wrote off as a uti and gave me a wide range of antibiotics.I could have died from that infection.I have been complaining for months about an unusual abdominal pain that was constantly overlooked.I went through all of that just to now be 7 weeks pregnant.The clips didn't even last 7 months as my last child is only 9 months old.I was told i was the 3rd person this month to come in having had that procedure and now pregnant.The clips must still be inside me and causing the crippling pains i constantly go through.I need them found and then removed before it kills me.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE - NIKOMED LTD
• MDR Report Key: 10875184
• MDR Text Key: 217662969
• Report Number: MW5097988
• Device Sequence Number: 1
• Product Code: KNH
• 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: 11/17/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 30 YR
• Patient Weight: 101