MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS; MESH, SURGICAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The initial onset date was reported as an unknown month and date in 2016.The initial reporter¿s postal code was reported as: ng5 1pb and phone extension reported as x55039.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an inflammatory reaction related to a veritas device.The event was further described as incomplete integration with an unusual yellowy collection of fluid; with an implant displacement following breast surgery.It was not reported if the patient was hospitalized for the event.Treatment details were not reported.The patient outcome and recovery status of the patient was not reported.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; ni; saint paul MN 55144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6150978
• MDR Text Key: 61625470
• Report Number: 1416980-2016-18111
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other