MAUDE Adverse Event Report: FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION

Device Problems Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problems Ectopic Pregnancy (1819); Itching Sensation (1943); Rash (2033)

Event Date 01/01/2004

Event Type  No Answer Provided  

Event Description

Patient called to report adverse event involving her tubal ligation device.Patient stated that after her implanting surgery, her right leg didn't work and it took 4 days for it to start working again.Patient also stated she¿s been to the doctor 9 times in the last 8 years due to an itchy rash on her stomach and arms.Patient said her doctor refused to remove the device.Patient said she has experienced an ectopic pregnancy.Patient said it¿s been hard for her to get a job because of the rash and itching, and she would like the device removed.

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
• MDR Report Key: 7934425
• MDR Text Key: 123117361
• Report Number: MW5080357
• 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: 10/03/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR