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

Model Number	AVM-851
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	08/04/2016
Additional Manufacturer Narrative
This event was reported by the fda to (b)(4), incorrectly identified on report no mw5064294 as the manufacturer.(b)(4) is the distributor of the filshie clip system in the u.S.Femcare-nikomed ltd.(femcare), is the actual device manufacturer.Femcare is filing this report out of caution because a medwatch report was previously filed by medical facility indicating an adverse event, although we have been unable to connect with a medical practitioner to confirm that the event required surgical intervention to avoid risk of serious injury.If clinical input becomes available that suggests medical or surgical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure femcare will augment this report accordingly.Device not returned to manufacturer.
Event or Problem Description
Femcare-nikomed received the following report from fda via a medwatch report submitted by a medical facility risk manager, reference mw5064294.Patient had a filshie tubal ligation procedure (b)(6) 2016.Post-op the patient complained of pain, cramping and discomfort.Patient was re-admitted for removal of filshie clips on (b)(6) 2016.

• Brand Name: FILSHIE CLIP SYSTEM
• Common Device Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD; stuart court, spursholt place; salisbury road; romsey, hampshire SO51 6DJ; UK SO51 6DJ
• MDR Report Key: 6221833
• Report Number: 8021955-2016-00002
• Device Sequence Number: 16245102
• Product Code: KNH
• UDI-Device Identifier: 05055515602121
• UDI-Public: 05055515602121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P920046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• 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 Expiration Date: 10/31/2018
• Device Model Number: AVM-851
• Device Catalogue Number: AVM-851
• Device Lot Number: 36105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 01/04/2017
• 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: Other