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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MESH, SURGICAL

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BAXTER HEALTHCARE CORPORATION MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
March 2012 through june 2016 the reported product is an unknown baxter peri-strips dry with veritas. Initial reporter address - florida international university literature article: gagner, m. , kemmeter, p. ¿comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review¿. Surg endosc. 2020 jan;34(1):396-407. Doi: 10. 1007/s00464-019-06782-2. Epub 2019 apr 16. 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 34 patients underwent laparoscopic sleeve gastrectomy¿s in which peri-strips were used. It was reported the patients experienced staple-line leaks following the procedure. It was not reported if the patients were hospitalized for the event. Treatment for the events was not reported. No further details were provided regarding medical interventions or patient outcomes. No additional information is available.
 
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Brand NameNI
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 Key13048309
MDR Text Key282725222
Report Number1416980-2021-07432
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2021
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: 12/20/2021 Patient Sequence Number: 1
Treatment
FLOSEAL/TISSEEL; GORE SEAMGUARD; IFABOND OR EVICEL GLUE
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