MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES JAY UNION CUSHION; JAY CUSHION

Model Number JU2018

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Pressure Sores (2326)

Event Date 08/21/2014

Event Type  Injury  

Event Description

An adverse event involving a jay union cushion was reported to sunrise medical on (b)(6) 2014.The dealer reported that the end-user is bottoming out on the cushion.As a result, the end-user has developed stage 2 pressure sores near the ischial region of their bottom.

Manufacturer Narrative

A good faith effort was made to obtain all required info for the filing of this mdr.However, the end-user's gender and age has not been provided at the time of this filing.If and when the required info is obtained, it will be submitted in a supplemental mdr.It appears that the wheelchair and/or parts involved in this incident are being returned to sunrise medical.If and when the chair/parts are received, our internal failure investigator will complete the investigation and a follow up report will be filed.

• Brand Name: JAY UNION CUSHION
• Type of Device: JAY CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no.110 parque industrial; misiones de las californias; tijuana, baja CA 22425
• Manufacturer Contact: jeremy ybarra, specialist ; 2842 business park dr.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 4109289
• MDR Text Key: 4703652
• Report Number: 9616084-2014-00003
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JU2018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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): Required Intervention
• Patient Weight: 77