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U.S. Department of Health and Human Services

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

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FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
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).
 
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Brand Name
FILSHIE CLIP
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key9202827
MDR Text Key162660354
Report NumberMW5090439
Device Sequence Number1
Product Code KNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/17/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Age28 YR
Patient Weight80
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