FDA.reportPublic FDA data

MAUDE MDR 8923052

MDR report key
8923052
Report number
1721504-2019-00066
Event key
0
Event type
3
Date of event
2019-04-18
Date received
2019-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. KATIE SWENSON, CQE, CBA, CQPA
Address
1600 W MERIT PARKWAY SOUTH JORDAN 84095 US
Phone
801-801-8012
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MERIT CUSTOM KITCUSTOM KITMERIT MEDICAL SYSTEMS, INC.OEQK12-MZT8201AH1501571Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-220

Event Narratives#

N

Patient 1

THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER FROM THE SAME CUSTOMER WAS FOUND.

D

Patient 1

THE DISTRIBUTOR REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.