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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUBAL LIGATION - PARKLAND METHOD; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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TUBAL LIGATION - PARKLAND METHOD; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Dizziness (2194)
Event Type  Injury  
Event Description
Since my tubal ligation i have experienced near constant nausea and dizziness, pelvic pain, intense pain with ovulation, headaches that last for days with minimal relief from otc pain relievers.My muscles ache all the time and tense up about a week before my period.My pms is like early pregnancy symptoms (fatigue, nausea, dizziness, etc) i have near constant breast pain.My pms symptoms often last 3 weeks - 1 month.My period flow is heavier and consist of clots.(sometimes the size of my palm) i never experienced any of the above symptoms in correlation to my monthly cycles before the birth of my 3rd child/ tubal ligation.I have had my hormones checked.My thyroid checked 3xs in the span of 1 1/2 years and had cbc and cmet drawn all in normal limits.Also had a ct scan of my head which was normal.
 
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Brand Name
TUBAL LIGATION - PARKLAND METHOD
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
MDR Report Key9711779
MDR Text Key180042219
Report NumberMW5093014
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 Patient
Type of Report Initial
Report Date 02/11/2020
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? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age38 YR
Patient Weight57
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