NAKED CUSHION SEAT

Additional Manufacturer Narrative

THE DEALER ADVISED THAT THE PATIENT PRESENTED WITH REDNESS, HIVES, AND IRRITATION. HE STATED THAT THE REACTION WAS LOCALIZED TO AREAS OF HIS BODY IN CONTACT WITH THE SEAT AND BACK CUSHIONS, SPECIFICALLY BEHIND THE KNEES TO THE TOP OF HIS SHOULDERS. THE DEALER STATED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION AT A HOSPITAL EMERGENCY ROOM TO CONTROL THE REACTION. HE ADVISED THAT THE PATIENT WAS PRESCRIBED MEDICATION, BUT HE WAS NOT SURE OF THE SPECIFICS. HE DIDN'T BELIEVE RESPIRATORY INTERVENTION WAS REQUIRED. ONCE REMOVED FROM THE CUSHION AND TREATED, THE PATIENT HAD NO FURTHER REACTION. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED TO THE FDA, DUE TO THE ALLEGED INJURY AND MEDICAL TREATMENT REQUIRED. HOWEVER, THERE WAS NO ALLEGED MALFUNCTION/DEFICIENCY WITH THE DEVICE. THE CONTOUR CUSHIONS ARE CUSTOMIZED TO THE INDIVIDUAL USER, AND THEY WERE MADE ACCORDING TO THE SPECIFICATIONS PROVIDED BY THE DEALER. AN ALLERGIC REACTION IS PATIENT-SPECIFIC. THE DEALER ADVISED THAT THE PATIENT HAS USED A VINYL-COVERED CONTOUR SYSTEM IN THE PAST WITH NO ISSUES, SO HE ASKED FOR THE CUSHIONS TO BE REMADE UTILIZING THE SAME SPECIFICATIONS, BUT WITH A VINYL COVERING INSTEAD OF LYCRA.

Description of Event or Problem

THE DEALER REPORTED THAT THE PATIENT EXPERIENCED A SEVERE SKIN REACTION TO THE CONTOUR SEAT AND BACK CUSHIONS, WHICH WERE MANUFACTURED WITH A RUBBER BACKED LYCRA COVER.