MAUDE MDR 3739035

MDR report key
3739035
Report number
1523530-2014-00005
Event key
0
Event type
3
Date of event
2014-02-11
Date received
2014-03-08
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
CRAIG RAMMEL
Address
60 VISTA DR. VERSAILLES OH 45380 US
Phone
937-937-9375
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RITTEREXAMINATION TABLEMIDMARK CORP.LGX222-016R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-080

Event Narratives#

D

Patient 1

FACILITY CLAIMS TABLE UNINTENTIONALLY MOVED. NO INJURIES OCCURRED.

N

Patient 1

THE PRODUCT IS NOT BEING RETURNED FOR FURTHER EVALUATION. PRODUCT WAS EVALUATED ON SITE BY SERVICE PROVIDER. THEY COULD NOT FIND ISSUE WITH THE PRODUCT. NO DAMAGE TO THE UNIT WAS FOUND. FUNCTION TESTING WAS PERFORMED TO ENSURE OPERATION OF UP/DOWN FEATURES. NO MISALIGNMENT WAS FOUND. IT WAS ALSO NOTED THAT A DRAWER WAS IN A POSITION THAT COULD HAVE CAUSED INTERFERENCE. CAUTION IS NOTED FOR THIS CONDITION IN THE USER MANUAL STATING: "BE SURE THAT ALL PERSONNEL AND EQUIPMENT ARE CLEAR OF THE TABLE BEFORE ACTIVATING ANY FUNCTION. FAILURE TO DO SO COULD RESULT IN PERSONAL INJURY."