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

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330)

Event Date 02/01/2020

Event Type  Injury  

Event Description

I had a device called the filshie clips put on my fallopian tubes when i was (b)(6).I recently turned (b)(6) and shortly after that i started to notice extreme pain in my lower abdomen and discomfort, after multiple doctors appointments ruling out possible causes and lots of testing to rule out and underlining conditions, it was determined that the filshie clips that i had put on had failed and migrated to another part of my body and we're causing the pain; after that surgery was scheduled to have found and removed.After they have been removed all pain has gone away confirming that they were the cause of the pain and discomfort.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: 10770354
• MDR Text Key: 214358751
• Report Number: MW5097594
• 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: 10/29/2020

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: 10/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 91