NEO LOOP
Received Jul 18, 2007 · Event occurred Jun 7, 2007
Report 2939821-2007-00002 · MDR key 883029
Device
Generic name
Splint Strapping
Manufacturer
North Coast Medical, Inc.Model number
NC15760Catalog number
NC15760
Lot number
NA
Product problems
- Replace
Patient
YR
- Staphylococcus Aureus
- Scarring
- Identified diagnosis
- Hospitalization required
Narrative
Description of Event or Problem
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).
Additional Manufacturer Narrative
UNABLE TO OBTAIN INFORMATION FROM HOSPITAL AND CLINIC. UNUSED MATERIAL FROM USER TO BE RETURNED TO MANUFACTURER FOR TESTING OF STAPHYLOCOCCUS AUREUS BACTERIA.
Remedial action
- Inspection