MAUDE Adverse Event Report: FEMCAER LTD. TUBAL FILSHIE CLIP ; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCUSION DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Emotional Changes (1831); Pain (1994)

Event Type  Injury  

Event Description

The filshie clip that was on my left ovary migrated to my stomach near my kidneys.I am in serious pain all of the time.I am in fear that if the clip doesn't get removed, that it will migrate to my colon, and cause me to die.I am also in fear that i could have inflammation in my stomach from the clip migrating.Fda safety report id# (b)(4).

• Brand Name: TUBAL FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCUSION DEVICE
• Manufacturer (Section D): FEMCAER LTD.
• MDR Report Key: 9575596
• MDR Text Key: 174668885
• Report Number: MW5092149
• 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: 01/08/2020

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: 01/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 39 YR
• Patient Weight: 77