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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION VERITAS MESH, SURGICAL Back to Search Results
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.
 
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Brand NameVERITAS
Type of DeviceMESH, 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 Key12298005
MDR Text Key265811522
Report Number1416980-2021-04902
Device Sequence Number1
Product Code FTM
Combination Product (y/n)Y
Reporter Country CodeSW
PMA/PMN Number
NI
Number of Events Reported1
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 Received08/09/2021
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 Received07/14/2021
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
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