FDA.reportPublic FDA data

MAUDE MDR 4440109

MDR report key
4440109
Report number
1031623-2015-00001
Event key
0
Event type
3
Date received
2015-01-21
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#

Address
PO BOX 4 WEST POINT PA 19486 US
Phone
215-215-2156
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310ORTHOSIS, CORRECTIVE SHOEKNPR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-2101. O

Event Narratives#

D

Patient 1

EVENT VERBATIM (LOWER LEVEL TERM). KNEE SURGERY (KNEE OPERATION). CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES AS RECEIVED FROM A CONSUMER REFERS TO A FEMALE PT OF UNK AGE. THIS REPORT CONCERNS 1 PT AND 1 DEVICE. THE PT USED THE ORTHOTIC (DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310) FOR AN UNK INDICATION. NO OTHER CO-SUSPECTS WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNK DATE, THE PT HAD KNEE SURGERY (MEDICALLY SIGNIFICANT). NO TREATMENT INFO WAS REPORTED. THE ACTION TAKEN AND THE OUTCOME WERE UNK. THE RELATEDNESS FOR THE PT HAVING KNEE SURGERY WAS UNK FOR THE ORTHOTIC (DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310). THE ORTHOTIC (DR. SCHOLL'S CUSTOM FIT ORTHOTICS CF 310) WAS NOT AVAILABLE FOR INVESTIGATION. FOR THE ORTHOTIC (DR. SCHOLL'S CUSTOMER FIT ORTHOTICS CF 310), THE LOT NUMBER WAS NOT AVAILABLE AND THE SERIAL NUMBER WAS NOT AVAILABLE. ADD'L INFO WAS NOT EXPECTED.

N

Patient 1

(B)(4).