FDA.reportPublic FDA data

MAUDE MDR 883029

MDR report key
883029
Report number
2939821-2007-00002
Event key
0
Event type
3
Date of event
2007-06-07
Date received
2007-07-18
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#

Address
18305 SUTTER BLVD. MORGAN HILL CA 95037 US
Phone
408-408-4087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEO LOOPSPLINT STRAPPINGNORTH COAST MEDICAL, INC.FZFNC15760NC15760NANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-07-1801. H; 2. O

Event Narratives#

D

Patient 1

HE CALLED ON 7/13/2007. HE SAID, HIS WIFE HAD A REACTION TO A STRAP USED ON AN AFO ANKLE AND FOOT ORTHOTIC. HE SAID, THE STRAPS WERE REPLACED ONE MONTH EARLIER, AND TWO DAYS LATER HIS WIFE HAD AN IRRITATION THAT HE SAYS REQUIRED 6 DAYS OF HOSPITALIZATION. AT THAT TIME, HE STATED HIS WIFE CONTRACTED A STAPH INFECTION (STAPHYLOCOCCUS AUREUS BACTERIA). HUSBAND STATES THIS RESULTED IN A PERMANENT SCAR. ONE MONTH LATER, THE STRAP WAS REPLACED AND THE AFO ORTHOTIC WAS DISINFECTED. (THE DATES WERE VERIFIED WITH FINGER LAKES PROSTHETICS AND ORTHOTICS).

N

Patient 1

UNABLE TO OBTAIN INFORMATION FROM HOSPITAL AND CLINIC. UNUSED MATERIAL FROM USER TO BE RETURNED TO MANUFACTURER FOR TESTING OF STAPHYLOCOCCUS AUREUS BACTERIA.