FDA.reportPublic FDA data

MAUDE MDR 925156

MDR report key
925156
Report number
1721504-2007-00039
Event key
0
Event type
3
Date of event
2007-07-30
Date received
2007-10-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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.GDXNASMS211UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-10-100

Event Narratives#

D

Patient 1

THE COMPLAINANT REPORTED, THAT THE INNER PORTION OF THE SAFETY SCALPEL CAME OUT THE BACK WHEN CLOSING THE DEVICE AFTER USE. IT WAS REPORTED THAT THE INNER PORTION FLEW ACROSS THE ROOM AND HIT THE WALL. THERE WAS NO REPORTED PATIENT OR CLINICIAN HARM OR INJURY.

N

Patient 1

METHOD: COMPLAINT DATA WAS REVIEWED; RESULTS: SCALPEL; CONCLUSIONS: NO CONCLUSION CAN BE DRAWN, UNUSUAL EVENT. MERIT MADE ATTEMPTS TO LOCATE THE SUSPECT DEVICE; HOWEVER, THE DEVICE COULD NOT BE FOUND. THE DEVICE MAY HAVE BEEN DISCARDED. A LOT NUMBER WAS NOT GIVEN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THERE WERE NO RELATED INCIDENTS IDENTIFIED IN THE COMPLAINT DATABASE. THE SUSPECT DEVICE WAS NOT RETURNED AND, THEREFORE, NO CONCLUSION CAN BE DRAWN. MERIT CONSIDERS THIS A RARE OCCURRENCE AND WILL MONITOR FOR ANY INCREASING TREND.