ACHILLES EXPRESS
Received May 19, 2011 · Event occurred Mar 28, 2011
Report 9613445-2011-00005 · MDR key 2098580
Device
Generic name
Bone Sonometer
Manufacturer
Ge Hangwei Medical Systems CoProduct problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PT AGE AND WEIGHT ARE NOT KNOWN AT THIS TIME. DATE APPROXIMATED AS 3 WEEKS BEFORE (B)(4) 2011. THE EXACT INCIDENT DATE HAS NOT BEEN REPORTED. SERIAL NUMBER HAS NOT BEEN MADE AVAILABLE. DEVICE MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A SERIAL NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT A WOMAN SCANNED ON AN ACHILLES EXPRESS EXPERIENCED ANKLE PAIN FOLLOWING A TEST THAT WAS ADMINISTERED AT A HEALTH FOOD STORE. THREE WEEKS LATER SHE WAS CONTACTED AND STATED THAT THE PAIN WAS STILL PRESENT. THE EXTENT OF THE ALLEGED INJURY HAS NOT BEEN DETERMINED. THE WOMAN HAS NOT BEEN EVALUATED BY A MEDICAL PROFESSIONAL.