Customer claims that he developed a stage 4 pressure sore due to cushion going flat but roho, inc.Has not seen medical records to confirm this.The manufacturing records were reviewed and indicated the cushion passed all inspections and verifications.It is unclear if product malfunction caused or contributed to the pressure wound as the product was not returned for evaluation.The user has warning in the manual to discontinue use of a defective product that reads as follows: "check skin frequently, at least once a day.Redness, bruising, or darker areas (when compared to normal skin) may indicate superficial or deep tissue injury and should be addressed.If there is any discoloration to skin/soft tissue, stop use immediately.If the discoloration does not disappear within 30 minutes after disuse, immediately consult a healthcare professional.- check inflation frequently, at least once a day.- do not use a product that is underinflated or overinflated, because 1) the product benefits will be reduced or eliminated, resulting in an increased risk to skin and other soft tissue" the user is hospitalized due to unrelated illness and is unable to return cushion to roho, inc at this time.Therefore, a product evaluation could not be performed.If additional information is received, a follow-up report will be submitted.
|