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

Catalog Number AVM-851

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Cramp(s) (2193); Heavier Menses (2666)

Event Date 11/23/2020

Event Type  Injury  

Event Description

Hsg procedure; since tubal ligation in 2012, i have experienced much more painful cramping during menstruation, as well as a much heavier blood flow; to the point that my doctor has suggested an iron supplement and ultrasound for further investigation if not brought under control.9 yrs after tubal ligation, i had xrays at the chiropractor.Noticed that my left filshie clip has migrated to my lower abdomen.Gyn performed necessary hsg procedure on (b)(6) 2020 to ensure tubes are indeed closed.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LIMITED / FEMCARE LTD
• MDR Report Key: 11064835
• MDR Text Key: 223609032
• Report Number: MW5098497
• 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: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AVM-851
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 71