MAUDE Adverse Event Report: FEMCARE-NIKOMED LTD FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Migration (4003)

Patient Problems Pain (1994); Weight Changes (2607); Breast Discomfort/Pain (4504)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Density in breast, loss of weight, pelvic pain, filshie clips migrated to ribs.Problems may have to have surgery.Hypertension - because of filshie clips.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD
• MDR Report Key: 10836398
• MDR Text Key: 216327181
• Report Number: MW5097823
• Device Sequence Number: 1
• Product Code: KNH
• 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: 11/09/2020

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 54