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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

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SORIN GROUP ITALIA S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING Back to Search Results
Model Number AF-836
Device Problems Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative

The manufacturer is in the process of obtaining additional information about this event. Device disposition not presently known.

 
Event Description

It was reported that an annuloflex, size 36, was implanted and "removed" on (b)(6) 2018. No other information was provided.

 
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Brand NameANNULOFLEX MITRAL ANNULOPLASTY RING
Type of DeviceMITRAL ANNULOPLASTY RING
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vc 13040
IT  13040
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia
Manufacturer Contact
francesca crovato
5005 north fraser way
burnaby, bc  
MDR Report Key7695120
Report Number3005687633-2018-00175
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/09/2019
Device MODEL NumberAF-836
Device Catalogue NumberAF-836
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/09/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2018 Patient Sequence Number: 1
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