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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Foreign Body Reaction (1868); Headache (1880); Pain (1994); Cognitive Changes (2551); Heavier Menses (2666)

Event Date 08/01/2010

Event Type  Injury  

Event Description

Pt was implanted with filshie clips in 2010.In (b)(6) of 2011, the pt said she was hospitalized in the icu for a few months due to her immune system attacking her body.Pt stated that her body was rejecting the filshie clips as a foreign object.Pt said she was hospitalized again in 2015 for a few weeks for autoimmune disease.Pt stated she now has cognitive delays, autoimmune disease, stronger periods, extreme back pain, and migraines.Pt stated before the filshie clips were implanted she had no medical problems.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 9729085
• MDR Text Key: 180629899
• Report Number: MW5093089
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/18/2020

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR