MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES JAY(R) J2 CUSHION; WHEELCHAIR CUSHION

Model Number 4250

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

The jay cushion involved in this adverse event did not malfunction nor is it defective.The client stated that he has not yet sought medical attention as the "area of the sore was darker for awhile before it became a pressure sore.It became a pressure sore recently, like yesterday or the day before." patient stated that he "is getting medical attention tomorrow." based on the information provided by the end user, it is our reasonable conclusion that the end user should have stopped using the cushion and sought medical care prior to the development of a pressure sore.

Event Description

Patient reported development of pressure sore on left side hip area.At time of report, medical attention had not been sought, but was intending to seek medical attention the day after reporting the issue to sunrise.The patient did admit that skin discoloration began some number of time previously, but did not seek care or file a complaint at that time.He was seeking a new cushion and was referred back to the dealer to procure a new cushion.Due to the user not seeking earlier medical attention, it is unsure as to whether the cushion actually contributed or caused to the skin breakdown or whether it was due to patient negligence.This mdr is being filed out of an abundance of caution.No further investigation will be performed at this time.Should additional information come to light in the future, a follow-up will be filed at that time.

• Brand Name: JAY(R) J2 CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer (Section G): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, ca ; 2942374
• MDR Report Key: 10282975
• MDR Text Key: 199089907
• Report Number: 9616084-2020-00004
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4250
• Device Catalogue Number: 4250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 40 YR
• Patient Weight: 77