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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. BOVINE XENOSURE BIOLOGIC PATCH; CAROTID PATCH

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LEMAITRE VASCULAR, INC. BOVINE XENOSURE BIOLOGIC PATCH; CAROTID PATCH Back to Search Results
Lot Number XBU2659
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Bacterial Infection (1735); Swelling (2091); Chills (2191)
Event Date 11/13/2017
Event Type  Injury  
Event Description
Patient admitted (b)(6) 2017 with fever, chills, and increased swelling of right side of neck.Patient had a right endarterectomy with patch angioplasty on (b)(6) 2017 at (b)(6).Patient taken to the operating room on (b)(6) 2017 for i and d for surgical site.Neck abscess fluid has thus far revealed gram positive cocci.Patient qualities for an ssi.Streptococcus agalactiae.Bovine xenosure biologic patch lot xbu2659 exp date 04/28/2023 (noted on scanned implant record).01/28/2023 (noted on surginet output record).Prepared with 0.9 percent nss lot g130310 exp aug 2020.
 
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Brand Name
BOVINE XENOSURE BIOLOGIC PATCH
Type of Device
CAROTID PATCH
Manufacturer (Section D)
LEMAITRE VASCULAR, INC.
63 second ave.
burlington MA 01803
MDR Report Key7074824
MDR Text Key93625634
Report NumberMW5073662
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2023
Device Lot NumberXBU2659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age58 YR
Patient Weight65
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