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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - SAINT PAUL VERITAS MESH, SURGICAL Back to Search Results
Catalog Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Date of event: 2008 to 2018. (b)(6) ¿investigator initiated research of post market clinical follow-up study of veritas collagen matrix in breast reconstruction¿. (sling-assisted, implant-based breast reconstruction in edinburgh 2008-2018). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported 35 ¿implant losses¿ occurred on patients that underwent sling assisted breast reconstruction surgery in which veritas was used over a 10-year period. No further detail was provided regarding treatment, if hospitalization was required or the patient¿s outcome. No additional information is available.
 
Manufacturer Narrative
Correction: 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.
 
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Brand NameVERITAS
Type of DeviceMESH, 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 Key8866796
MDR Text Key153569959
Report Number1416980-2019-04304
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K062915
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
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 Received08/23/2019
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

Patient Treatment Data
Date Received: 08/06/2019 Patient Sequence Number: 1
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