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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE XENOSURE BOVINE PERICARDIUM PATCH MESH, SURGICAL

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LEMAITRE VASCULAR, INC. LEMAITRE XENOSURE BOVINE PERICARDIUM PATCH MESH, SURGICAL Back to Search Results
Catalog Number E1P6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/25/2022
Event Type  Injury  
Event Description
Pt had a carotid endarterectomy with patch done on (b)(6) 2020. She presented in (b)(6) 2022 with an infected patch requiring surgical intervention.
 
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Brand NameLEMAITRE XENOSURE BOVINE PERICARDIUM PATCH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LEMAITRE VASCULAR, INC.
MDR Report Key14282840
MDR Text Key290801105
Report NumberMW5109514
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberE1P6
Device Lot NumberXB43656
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/03/2022 Patient Sequence Number: 1
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