MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL VERITAS; MESH, SURGICAL

Catalog Number ASKU

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient underwent a para-esophageal hernia repair and nissen fundoplication in which veritas was used.It was reported after the surgery, the patient experienced nausea, vomiting, fatigue, loss of appetite, abdominal pain, and intestinal problems(unspecified).It was reported the veritas was adhering to the patient¿s internal organs and structures causing health issues.The patient underwent a surgery to remove the veritas mesh and repair the tissue and surrounding organs.At the time of this report, no further details were provided regarding hospitalization, further medical interventions and the patient¿s outcome.No additional information is available.

Manufacturer Narrative

Additional information: 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): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9199466
• MDR Text Key: 162707796
• Report Number: 1416980-2019-05613
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2019
• 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): Required Intervention