The customer alleged that a pressure injury developed due to delay in receiving replacement cushion after initial cushion went flat, but roho, inc.Has not seen medical records to confirm this.Shipping service delivered initial replacement to incorrect address.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.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 cushion was not returned to roho, inc.So an evaluation could not be performed.If new information is received, we will submit a follow up report.
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