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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 4D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING
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SORIN GROUP ITALIA S.R.L. MEMO 4D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING Back to Search Results
Model Number TBD
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
The manufacturer was informed that a patient received a memo 4d (implant date unknown).The blue template (holder) was reportedly not removed during the surgery, thus remaining implanted in the patient.The patient received reoperation in another center where the template was removed.It is reported that the patient required another surgery (not related to the memo 4d), and on this occasion, it was identified that the template was implanted in the patient.No symptoms were previously noted.
 
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Brand Name
MEMO 4D SEMIRIGID ANNULOPLASTY RING
Type of Device
MITRAL ANNULOPLASTY RING
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada crescentino snc
saluggia, vercelli 13040
IT  13040
MDR Report Key9446591
MDR Text Key175195809
Report Number1718850-2019-01201
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 Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/11/2019,12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTBD
Device Catalogue NumberTBD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/11/2019
Event Location Hospital
Date Report to Manufacturer11/11/2019
Date Manufacturer Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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