inforMED
InjuryFIL

AVAULTA BIOSYNTHETIC SUPPORT SYSTEM

Received Jun 20, 2009

Report 1018233-2009-00062 · MDR key 3618946

Device

Model number

NA

Catalog number

486010

Lot number

ZGJ00188

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.