• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FEMCARE, LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Tissue Damage (2104); Patient Problem/Medical Problem (2688)
Event Date 05/26/2016
Event Type  Injury  
Event Description
I had an emergency c section 14 months after a prior emergency c section and the gynecologist used staples following a tubal ligation.I am having nerve issues, bladder issues, suffered from a lot of health complications since my c section.I had filshie clips removed in (b)(6) of 2019 but i have a labia tear on mu right groin, and nerve damage still.My bladder functions at the age of a 14 yr old and i am (b)(6).I have had tests done on my bladder and have nerve conduction tests scheduled in the next few months also a test to try to figure out where the blood flow has been cut of they believe to my brain keeping me from getting proper circulation.Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FILSHIE CLIPS
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE, LTD.
MDR Report Key9641498
MDR Text Key176951065
Report NumberMW5092566
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 01/27/2020
2 Devices were Involved in the Event: 1   2  
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 Received01/28/2020
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age33 YR
Patient Weight66
-
-