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

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  Injury  

Event Description

Fertility issues; filshie clips were place (b)(6) 2017 and was notified after unrelated ct that the left clip has dislodged and migrated into the right pelvis.Previous ct done on (b)(6) 2019 showed now issues with clips.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12293827
• MDR Text Key: 265971346
• Report Number: MW5103077
• 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: 08/04/2021

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: 08/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 68