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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
Catalog Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 06/03/2020
Event Type  Injury  
Manufacturer Narrative
The reported product is an unknown baxter peri-strip. 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 a patient underwent a gastric sleeve procedure in which five peri-strips were used on eight staple fires. On an unreported date following surgery, the patient experienced a post-operative leak. The location of the leak was in the "upper 2 cm of the stomach". The cause of the leak was unknown. It was reported the patient required an extended hospitalization due to the leak. It was unknown if any medical intervention was associated with this event. At the time of this report, the patient outcome was unknown. 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 60073
2242702068
MDR Report Key10494464
MDR Text Key205683648
Report Number1416980-2020-05464
Device Sequence Number1
Product Code FTM
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
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 Initial

Patient Treatment Data
Date Received: 09/04/2020 Patient Sequence Number: 1
Treatment
COVIDIEN PRE-BUTTRESS
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