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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING Back to Search Results
Model Number 5200
Device Problem Device Damaged Prior to Use
Event Date 12/19/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned to edwards for evaluation. Attempts to retrieve the device and additional information are in process. The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation. Based on the information received, the package handling during transport likely led to the event. If additional information is received a supplemental mdr will be submitted. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

 
Event Description

Edwards received notification a customer received a 32mm annuloplasty ring box that was damaged from courier. As reported, the outermost shipper box (brown cardboard) and the product box both were damaged. The customer did not check the ring plastic blister wrap but suspected the sterility was compromised as the parcel was very crushed.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluation: the ring was returned in a shipper box which appeared undamaged, and in a shelf box which did not have any labeling. The ring remained inside of the double sealed tray. The tray had a "hold label"; label was removed for evaluation. A dent was observed on one of the corners of the outer tray. No damages were observed on the inner tray or ring. The lid label appeared to be wrinkled. Customer report of outermost shipper box (brown cardboard) and the product box both were damaged could not be confirmed as original shipper box and shelf box were not returned. Report of "ring blister" affected was confirmed. Based on the information received the handling of the device during shipment likely contributed to the event.

 
Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution. No issues were identified that would have impacted this event.

 
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Brand NameCARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
Type of DeviceANNULOPLASTY RING
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
trushala nerurkar
1 edwards way
ms lfs 33
irvine , CA 92614
9492501377
MDR Report Key6289199
Report Number2015691-2017-00223
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5200
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/14/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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