• 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 PUERTO RICO, INC. TAILOR FLEXIBLE RING AND BAND RING, ANNULOPLASTY

  • 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 PUERTO RICO, INC. TAILOR FLEXIBLE RING AND BAND RING, ANNULOPLASTY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative

Further information regarding this event has been requested. Investigation results will be provided in a subsequent submission.

 
Event Description

On (b)(6) 2020 the patient underwent an explant of their sjm tailor flexible ring and band due to dehiscence. The ring was replaced by edwards mitral magna. No patient consequences reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTAILOR FLEXIBLE RING AND BAND
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
00725
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
00725
Manufacturer Contact
pamela yip
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key10378334
MDR Text Key202004642
Report Number2648612-2020-00083
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received07/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/07/2020 Patient Sequence Number: 1
-
-