Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. BIOCOR PERICARDIAL PATCH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, BRASIL LTDA. BIOCOR PERICARDIAL PATCH Back to Search Results
Model Number B40-10X6
Device Problem Missing Information (4053)
Patient Problem Unspecified Infection (1930)
Event Date 11/22/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, a 6x10cm biocor pericardial patch was implanted.On (b)(6) 2018, the patch was explanted due to infection which was reportedly after aortic valve replacement and aortic root enlargement surgery.Additional information requested.
 
Event Description
On (b)(6) 2018, a 6x10cm biocor pericardial patch was implanted.On (b)(6) 2018, the patch was explanted due to infection which was reportedly after aortic valve replacement and aortic root enlargement surgery.Additional information was requested, but not available.
 
Manufacturer Narrative
The reported event of infection could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that the infection occurred after aortic valve replacement and root enlargement surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIOCOR PERICARDIAL PATCH
Type of Device
PERICARDIAL PATCH
Manufacturer (Section D)
ST. JUDE MEDICAL, BRASIL LTDA.
rua professor jose vieira de mendonça 1301
engenho nogueira - belo horizonte - mg
belo horizonte 31310 -260
BR  31310-260
MDR Report Key8196499
MDR Text Key131421075
Report Number3001883144-2018-00107
Device Sequence Number1
Product Code DXZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/25/2019
Device Model NumberB40-10X6
Device Catalogue NumberB40-10X6
Device Lot NumberBR00008809
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-