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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 Blood Loss (2597)
Event Date 04/02/2020
Event Type  Injury  
Manufacturer Narrative
The reported product is an unknown baxter peri-strip. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient underwent an unspecified gastric tissue surgery in which peri-strips were used. After application of the peri-strips, the physician tried to suture through the peri-strips, however, the stitches pulled the peri-strips off the tissue, which resulted in bleeding. The estimated volume of blood loss was 50 ml. Treatment for the event was not reported. At the time of this report, the patient outcome was reported as the ¿length of surgery was prolonged due to the bleeding¿. 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 Key9999992
MDR Text Key188968499
Report Number1416980-2020-02374
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2020
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 Unkown

Patient Treatment Data
Date Received: 04/27/2020 Patient Sequence Number: 1
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