MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC JAY SEATING CUSHION; WHEELCHAIR CUSHION

Model Number	JAY UNION CUSHION
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abrasion (1689); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user reports that after pivoting from the bed onto her wheelchair and fastening her positioning belt, she allegedly slid off the seat cushion and was suspended on the edge of the wheelchair for 10 hours.The end user stated that she slid off the cushion due to the wear of the wheelchair fitted cushion cover.The end user reports that after the incident, she was admitted into the hospital and subsequently a rehab facility.
Additional Manufacturer Narrative
Background information: jay union cushion owner's manual, rev.A, page 3 states: "check the cover for tears and excessive wear and or any other abnormalities." discussion: in reviewing the complaint, the end user reports that after pivoting from the bed onto her wheelchair and fastening her positioning belt, she allegedly slid off the seat cushion and was suspended on the edge of the wheelchair for 10 hours while affixed by the positioning belt.The wheelchair used during the incident was not a sunrise medical device.The end user reports that the fire department was called and had to help her out of the wheelchair.The end user stated that she slid off the cushion due to the wear of the wheelchair fitted cushion cover.According to the jay union cushion owner's manual, the end user is supposed to check the cover for tears and other excessive wear.There was no information provided on the maintenance for the cover in question.This device is used for treatment, not diagnosis.The end user reports that the wheelchair cushion cover has since been replaced.A dhr review for this product was conducted and no abnormalities, deviations or ncmr's related to the claim were identified in the manufacturing process.After the incident, the end user was transported to the hospital.The end user reports that she was admitted into the hospital for 11 days and then a rehabilitation facility for 14 days.The end user stated that during the incident, she allegedly sustained a knee and stomach abrasion with no stitches.The end user provided documentation from her hospital stay that stated the primary diagnosis was "rhabdomyolysis." there was no further diagnostic information provided by the end user that described the connection between the primary diagnosis and the reported incident.The end user stated that due to the incident, it has taken a while for her to feel safe in her wheelchair; she also provided that she has had nightmares since the incident.Conclusion: in conclusion, due to the allegation of a potential serious injury (rhabdomyolysis), this mdr is being filed.

• Brand Name: JAY SEATING CUSHION
• Common Device Name: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL TECNOLOGIAS S.A. DE CV; privada misiones no. 110; parque industrial misiones; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno
• MDR Report Key: 19169043
• Report Number: 9616084-2024-00009
• Device Sequence Number: 7938648
• Product Code: IMP
• UDI-Device Identifier: 00016958056402
• UDI-Public: 00016958056402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: JAY UNION CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female