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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Date of event: (b)(6) 2009 to (b)(6) 2014. Chang, craig g. ,thackeray, lisa. ¿laparoscopic hiatal hernia repair in 221 patients: outcomes and experience¿. Journal of the society of laparoendoscopic surgeons, (january¿march 2016): volume 20 issue 1 e2015. 00104. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient underwent a laparoscopic hiatal hernia repair to reduce and/or alleviate gastroesophageal reflux disease (gerd) symptoms and associated hiatal recurrence in which veritas was used as a biologic mesh re-enforcement. Veritas was placed over the cruroplasty, which was previously sutured using braided polyester sutures, and was used to strengthen the repair. This was then sutured to the diaphragm at multiple points using interrupted 0 vicryl sutures. The surgery was performed using an onlay technique (of the biological mesh). Post operatively, the patient developed an unspecified wound infection. The cause of the event was not specified. No further information was provided regarding if the patient was hospitalized for the event or if any medical interventions were needed. At the time of this report, the patient outcome 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.
 
Event Description
 
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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 Key8185228
MDR Text Key131036653
Report Number1416980-2018-07940
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062915
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
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 Received01/17/2019
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: 12/20/2018 Patient Sequence Number: 1
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