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U.S. Department of Health and Human Services

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

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FEMCARE - NIKOMED LTD FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Pregnancy with a Contraceptive Device (4517)
Event Date 02/03/2020
Event Type  Injury  
Event Description
Unwanted pregnancy; i was told that having the clips was the only option i had when getting my tubes tied after delivery.We had discussed it at my dr office for months and no other options were present.At the hospital, i stated again that i wanted them cut and was told the clips were permanent and i had nothing to worry about.On (b)(6) 2020, the day after delivery, the procedure with the filshie clips was done.After several failed attempts to properly place the needle and place the clips, i went to recover.I caught a severe infection that they wrote off as a uti and gave me a wide range of antibiotics.I could have died from that infection.I have been complaining for months about an unusual abdominal pain that was constantly overlooked.I went through all of that just to now be 7 weeks pregnant.The clips didn't even last 7 months as my last child is only 9 months old.I was told i was the 3rd person this month to come in having had that procedure and now pregnant.The clips must still be inside me and causing the crippling pains i constantly go through.I need them found and then removed before it kills me.Fda safety report id# (b)(4).
 
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Brand Name
FILSHIE CLIPS
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE - NIKOMED LTD
MDR Report Key10875184
MDR Text Key217662969
Report NumberMW5097988
Device Sequence Number1
Product Code KNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2020
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age30 YR
Patient Weight101
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