FDA.reportPublic FDA data

MAUDE MDR 1493632

MDR report key
1493632
Report number
1721504-2009-00127
Event key
0
Event type
3
Date of event
2009-09-25
Date received
2009-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEPHANIE ERSKINE
Address
1600 MERIT PKWY. SOUTH JORDAN UT 84095 US
Phone
801-801-8012
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FUTURA SAFETY SCALPELSCALPEL, ONE-PIECEMERIT MEDICAL SYSTEMS, INC.GDXNASMS210/CD914622N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-10-050

Event Narratives#

D

Patient 1

REASON FOR PRODUCT RECALL: MERIT MEDICAL SYSTEMS, INC. IS RECALLING A SPECIFIC SHIPMENT OF PRODUCTS DUE TO POTENTIAL STERILITY BREACH WHICH MAY HAVE BEEN CAUSED BY EXCESSIVE SHIPMENT DAMAGE. PLEASE NOTE THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL.

N

Patient 1

MERIT IS RECALLING PRODUCTS OF A SPECIFIC SHIPMENT DUE TO A POTENTIAL STERILITY BREACH WHICH MAY HAVE BEEN CAUSED BY EXCESSIVE SHIPMENT DAMAGE. A DELIVERY TRUCK TRANSPORTING THE PRODUCTS WAS INVOLVED IN A ROLL-OVER ACCIDENT; NEVERTHELESS, THE DELIVERIES WERE MADE WITHOUT MERIT'S CONSENT. DEVICE EVALUATION: THE DEVICE PACKAGING WILL BE INSPECTED IF RETURNED. IF THE PRODUCT WAS USED AND RETURNED, IT WILL BE EVALUATED. EVALUATION CODES: CONCLUSIONS - IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED TO FDA IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.