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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 4D ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING
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CORCYM S.R.L. MEMO 4D ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING Back to Search Results
Model Number 4DM-30
Medical Device Problem Code Insufficient Device Problem Information (3190)
Date of Event 12/03/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The manufacturer was informed of this event through patient tracking database.Based on the information received from the patient registration form, the memo 4d size 30 was implanted and explanted intra-operatively on (b)(6) 2022.No further information is presently available.No allegation of a device malfunction nor of a serious injury for the patient was received from the field regarding this event.
 
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Brand Name
MEMO 4D ANNULOPLASTY RING
Common Device Name
MITRAL ANNULOPLASTY RING
Manufacturer (Section D)
CORCYM S.R.L.
strada crescentino
saluggia, vercelli 13040
IT  13040
MDR Report Key13765656
Report Number3019892983-2022-01018
Device Sequence Number11715490
Product Code KRH
UDI-Device Identifier08022057015433
UDI-Public(01)08022057015433(240)4DM-30(17)230306
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/14/2022
Report Date (Section F) 02/17/2022
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/06/2023
Device Model Number4DM-30
Device Catalogue Number4DM-30
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/17/2022
Device Age44 MO
Event Location Hospital
Date Report to Manufacturer02/17/2022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/15/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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