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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER SURGICAL / FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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COOPER SURGICAL / FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Defective Component (2292)
Patient Problems Pain (1994); Toxicity (2333); Heavier Menses (2666)
Event Date 01/08/2020
Event Type  Injury  
Event Description
In 2011 i had filshie clips put in (b)(6).The dr placed 4 filshie on both my fallopian tubes, two on each side.Two years later, i started experiencing pain and heavy bleeding.Years of pain and misdiagnoses; later we discovered that they had migrated.I had 3 of the filshie clips removed in (b)(6) on (b)(6) 2020.I now have to have a ct scan to find the missing 4th filshie clip.This has caused me to loose jobs and relationships.My children have been watching their mother suffer.These clips need to be pulled from the market.There are millions of women experiencing the same issues.These are toxic and defected.Please protect united states citizens by not allowing these to be used any further.This has been a nightmare.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)
COOPER SURGICAL / FEMCARE LTD.
MDR Report Key9596273
MDR Text Key175699971
Report NumberMW5092300
Device Sequence Number2
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 Patient
Type of Report Initial
Report Date 01/14/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
Patient Weight79
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