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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Thrombus (2101); Rupture (2208); Blood Loss (2597)

Event Date 08/26/2019

Event Type  Death  

Event Description

Pt had a tubal ligation with filshie clips on (b)(6) 2017 with subsequent pregnancy one year later.Pt had a uterine rupture prior to the laparoscopic tubal with fetal demise and again after the failed tubal, she also had a uterine rupture with fetal demise in 2019.During the emergency surgery, the filshie clips were not on the tubes and one was found floating in the abdomen among the blood clots, the other was not found.Pt required blood transfusion.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: 9202827
• MDR Text Key: 162660354
• Report Number: MW5090439
• 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: Physician
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 28 YR
• Patient Weight: 80