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

Model Number	AVM-851
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Increased Sensitivity (2065); Discomfort (2330); Complaint, Ill-Defined (2331)
Date of Event	07/01/2014
Additional Manufacturer Narrative
Femcare is filing this report because surgical intervention to remove clips reportedly resolved serious allergy symptoms.No disability/permanent damage was reported.According to an independent medical expert practitioner, the reported pelvic congestion syndrome is not reasonably related to the use of filshie clips.Not returned to manufacturer.
Event or Problem Description
Femcare-nikomed received the following report from fda via a medwatch report submitted by a patient, reference mw5064826.The patient had a bilateral tubal ligation with filshie clips in 2014.Within 6 weeks of the tubal ligation procedure patient reported she began suffering from a number of symptoms including; joint pain, hair loss, breast pain, cystic acne, enlarged lymph nodes, nasal allergies, fatigue, short term memory issues, light headed/dizziness, shortness of breath, heavy menstrual cycles and bilateral pelvic pain/burning sensation.The patient stated that she has a nickel allergy.The patients' doctor agreed the clips needed to be removed.The patient had a laparoscopic bilateral salpingectomy with filshie removal in 2016.Enlarged veins were viewed on and around the patients' uterus reportedly signalling pelvic congestion.The patient believes the filshie clips played a role in the development of pelvic congestion and were the cause of the other symptoms reported.The patient reports that with the exception of hair loss, all symptoms have ceased.

• Brand Name: FILSHIE CLIP SYSTEM
• Common Device Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE, LAPAROSCOPIC
• Manufacturer (Section D): FEMCARE-NIKOMED LTD; stuart court, spursholt place; salisbury road; romsey, hampshire SO51 6DJ; UK SO51 6DJ
• MDR Report Key: 6228146
• Report Number: 8021955-2016-00003
• Device Sequence Number: 19067147
• Product Code: KNH
• UDI-Device Identifier: 05055515602121
• UDI-Public: 05055515602121
• Combination Product (Y/N): N
• PMA/510(K) Number: P920046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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
• Operator of Device: Health Professional
• Device Model Number: AVM-851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR