FDA.reportPublic FDA data

MAUDE MDR 4664173

MDR report key
4664173
Report number
2921578-2015-00008
Event key
0
Event type
3
Date of event
2015-01-01
Date received
2015-03-17
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
ANNE LEBLANC
Address
30031 AHERN AV UNION CITY CA 94587 US
Phone
510-510-5104
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1E-THOTICSPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE, PRODUCT CODE: NOCFIXES 4 KIDSNOC* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-1701. R

Event Narratives#

D

Patient 1

CUSTOMER IS COMPLAINING THAT THEY ARE FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS ON ADJUSTING THE TENSION OF THE E-THOTIC; HOWEVER, BASED UPON THEIR LAST TWO PATIENTS THEY ARE FINDING THE DEVICE IS DIFFICULT TO ADJUST AND ARE HAVING TO REMOVE THE BRACE EARLIER THAN REQUIRED. AS SUCH, THE KEY SURGEON FOR THIS DEVICE HAS STATED, "I AM HOLDING OFF ON FURTHER USE FOR NOW". ADDITIONALLY, THE CUSTOMER IS RETURNING ALL UNUSED E-THOTICS, PIN GUIDES, PIN GUIDE HOLDER AND FIXTURE (101,103, 201,202, & 203). THE SURGEON IS STATING, "MY LAST TWO PATIENTS ENDED UP IN THE ER WITH SWELLING THAT REQUIRED REMOVING THE E-THOTIC EARLY."

N

Patient 1

INITIAL REPORT WAS FILED IN ERROR. DEVICE IS NOT IMPORTED.