MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VERITAS MESH, SURGICAL

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

Patient Problems Unspecified Infection (1930); Perforation (2001); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years of age or older. Stage i operations: 2016 to 2018. Initial reporter facility name: (b)(6) hospital. Literature article: hansson e. , edvinsson a. C. , elander, a. , kölby, l. And hallberg, h. ¿first-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: a randomized controlled study¿. J surg oncol. (2021); 123:80¿88. Doi: 10. 1002/jso. 26227. 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.

Event Description

It was reported 16 patients experienced post-operative events after bilateral mastectomy and immediate breast reconstruction surgeries were performed using veritas. It was reported nine patients experienced seroma, four patients experienced infections, one patient experienced an implant loss due to infection and two patients experienced expander loss due to infection. It was reported that an unspecified number of seromas required aspiration. It was reported an unspecified number of patients were treated with unspecified antibiotics for the infection. It was reported the implant loss required removal. No further detail was provided regarding if hospitalization was required or the patient¿s outcome. No additional information is available.

• Brand Name: VERITAS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12298005
• MDR Text Key: 265811522
• Report Number: 1416980-2021-04902
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/09/2021 Patient Sequence Number: 1