MAUDE Adverse Event Report: COOPERSURGICAL, INC/FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994); Urticaria (2278); Weight Changes (2607)

Event Date 01/25/2015

Event Type  Injury  

Event Description

Right after surgery for tubes being tied with filshie clips.I had an ongoing infection that lasted months after the tubal.Stabbings pains, ovarian cyst that i never had prior to getting tubes tied, weight gain, hives etc.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC/FEMCARE LTD.
• MDR Report Key: 8866365
• MDR Text Key: 153641618
• Report Number: MW5088837
• 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: 08/04/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR