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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 PSD6006UV
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
The reported product is an unknown baxter peri-strip. 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 eight peri-strips were used with eight staple fires. It was reported that the hospital was out of naked non-baxter staple loads and ¿removed the buttress from the pre-loads, then adhered the peri-strips to them¿. On an unreported date, 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 reported the patient required a ¿redo¿ (additional surgical intervention due to the leak) and went to a different facility. 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 Key10495412
MDR Text Key205711466
Report Number1416980-2020-05490
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,Followup
Report Date 10/07/2020
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 NumberPSD6006UV
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
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
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