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

Model Number AVM-851

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 08/04/2016

Event Type  No Answer Provided  

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 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
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD; stuart court, spursholt place; salisbury road; romsey, hampshire SO51 6DJ; UK SO51 6DJ
• Manufacturer (Section G): FEMCARE-NIKOMED LTD; stuart court, spursholt place; salisbury road; romsey, hampshire SO51 6DJ; UK SO51 6DJ
• Manufacturer Contact: howard beaumont ; stuart court, spursholt place; salisbury road; romsey, hampshire SO51 -6DJ ; UK SO51 6DJ ; 794525100
• MDR Report Key: 6221833
• MDR Text Key: 63844131
• Report Number: 8021955-2016-00002
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 05055515602121
• UDI-Public: 05055515602121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other