MAUDE Adverse Event Report: SUNRISE MEDICAL TECHNOLOGIAS JAY XTREME ACTIVE CUSHION; JAY CUSHION

Model Number JAY XTREME ACTIVE

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The product in question is the jay xtreme active cushion.The rubber logo is sewn into the side of the cushion cover that sits below the rim of the cushion.This type of logo is used on covers for cushions that are manufactured and distributed in the united states as well; which is why this incident is being reported.This is the first time an incident of this kind has been reported to sunrise medical from any location world-wide.Since this cushion was not returned to sunrise medical, our quality team evaluated a similar cushion and attempted to duplicate the same effect without success that the end user is allegedly claiming is being caused by her cushion.The end user also claims that she does have feeling to the "bell" and thighs of her legs, however, kept using the cushion after several doctor visits even though it was allegedly causing the sores and scrapes.The end user has removed the logo from the cushion cover and has had no recurrence of the complaint.Sunrise medical's quality department will be performing an in depth assessment and monitor for trends.Sunrise medical's legal counsel is addressing her concerns and her claim.There will be no further investigation as there is no risk to public health identified.

Event Description

The following complaint was received on (b)(6) 2018 from an end user in (b)(6): i have used your jay pillow with cover for 20 years and it has gone well.I got a new cover for the pillow and after about a month i got sores and skin scrapes on my left bell / thighs.I find out that when i moved from the bed to the chair, the bell and thighs scratch your new logo.Your new logo is made of stiff rubber, it destroys my skin and i have to spend days in the hospital.I am now full of ugly scars and it hurts very much.

• Brand Name: JAY XTREME ACTIVE CUSHION
• Type of Device: JAY CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL TECHNOLOGIAS; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 7427404
• MDR Text Key: 105371680
• Report Number: 9616084-2018-00003
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY XTREME ACTIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization