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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC BIOCAL 370 SN

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MEDTRONIC BIOCAL 370 SN Back to Search Results
Model Number BIO/CAL 370 SN
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 07/15/2015
Event Type  Injury  
Event Description

Pt developed mycobacterium abscessus infection approx 4 months post cabg x 3 and aortic valve replacement.

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Brand NameBIOCAL 370 SN
Type of DeviceBIOCAL 370 SN
Manufacturer (Section D)
minneapolis MN 55422
MDR Report Key5117839
MDR Text Key27310660
Report NumberMW5056737
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHYSICIAN
Type of Report Initial
Report Date 09/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2015
Is This An Adverse Event Report? Yes
Device EXPIRATION Date04/24/2018
Device MODEL NumberBIO/CAL 370 SN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Date Received: 09/24/2015 Patient Sequence Number: 1