InjuryFIL
AVAULTA BIOSYNTHETIC SUPPORT SYSTEM
Received Jun 20, 2009
Report 1018233-2009-00062 · MDR key 3618946
Device
Product problems
- Device remains implanted
Patient
UNK
- Pain
- Surgical procedure, additional
Narrative
Description of Event or Problem
IT WAS ALLEGED BY THE PATIENT'S ATTORNEY: "FOLLOWING AN ANTERIOR REPAIR AND A POSTERIOR REPAIR PERFORMED IN 2007, THE PATIENT EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING, PERMANENT INJURY, PHYSICAL DEFORMITY, LOSS OF A BODILY ORGAN SYSTEM AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES". AN INQUIRY WAS FORWARDED TO THE PATIENT'S PHYSICIAN WHO RESPONDED THAT ALL INQUIRIES CONCERNING THIS PATIENT SHOULD BE FORWARDED TO HIS ATTORNEY. THE PATIENT'S ATTORNEY PROVIDED THE PATIENT'S IMPLANT CARD. THE DIAGNOSIS AND TYPE OF TREATMENT FOR THIS SPECIFIC PATIENT IS NOT KNOWN.