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

Model Number JAY J2DC CUSHION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

Background information: jay j2 deep contour cushion owner's manual rev.D, page 2 states: "warning! prior to prolonged sitting, any cushion should be tried for a few hours at a time while a clinician inspects your skin to ensure that red pressure spots are not developing.You should regularly check for skin redness.The clinical indicator for tissue breakdown is skin redness.If your skin develops redness, discontinue the use of the cushion immediately and see your doctor or therapist." jay j2 deep contour cushion owner's manual rev.D, page 2 states: "warning! your jay cushion is designed to help reduce pressure.However, no cushion can completely eliminate sitting pressure or prevent pressure sores.The jay cushion is not a substitute for good skin care including, proper diet, cleanliness, and regular pressure relief." discussion: in reviewing the complaint, the dealer reports that they noticed air was in the fluid bladder when the end user came in for an evaluation.The dealer further reports there was nothing abnormal when they released the cushion to the end user upon initial inspection.There was no additional information provided on the condition of the cushion.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.The jay2 dc cushion was made to specification.According to the dealer, the end user has allegedly developed a stage 3 pressure sacrum wound.There was no information provided on characteristics of the wound or current medical treatment for the end user.Conclusion: in conclusion, due to the allegations of a serious injury (stage 3 pressure wound), this mdr is being filed.

Event Description

Dealer reports that they noticed air in the fluid bladder when the end user came in for an evaluation.Dealer provides that the end user has allegedly developed a stage 3 pressure sacrum wound.This device is used for treatment, not diagnosis.

• Brand Name: JAY CUSHION
• Type of Device: 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, CA 93727
• MDR Report Key: 18808369
• MDR Text Key: 336570176
• Report Number: 9616084-2024-00005
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAY J2DC CUSHION
• Device Catalogue Number: JAY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 79 KG