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

Model Number JAY UNION

Device Problem Material Twisted/Bent (2981)

Patient Problem Pressure Sores (2326)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Background information: sunrise products that are ordered with cushions, are provided cushions per dealer/provider specifications.There are numerous cushion configurations; some are designed for individuals more prone to developing pressure sores and some are not.The determination of whether or which cushion is needed is the dealer/provider responsibility to specify as some users may be determined, by a mobility specialist, to need specific cushion types (fluid, gel, foam, etc.).This requirement cannot be determined by sunrise medical as we do not know the condition of the end user, nor the specific needs of their disability.When specific cushions are provided, per dealer requirements, the expectation is the cushion will be free of manufacturing defects and will perform in accordance with all written materials (website, owner manual, etc.).When cushions do not perform as intended, it is considered a malfunction of the device and pressure sores, whether a serious injury or not, have the potential for becoming a serious injury.Therefore, all malfunctions of wheelchair cushions are considered reportable events.Discussion: the current complaint mentions that the gel packet inside the jay union cushion detached from the foam base and then rolled into a ball creating a pressure point under the user's buttock.He reported that he developed a pressure sore, but also stated it was not an injury.Therefore, the presumption is that it was an early stage (level 1) pressure sore that did not break the skin.However, left untreated this type of injury can progress to a serious injury.Conclusion: due to the malfunction of the cushion and an injury with the potential for developing into a serious injury, this mdr is being filed.Additional information: this complaint has been re-reviewed as a part of a four-year retrospective review and remediation effort based on enhancements made to the company's complaint handling and adverse event reporting processes.A legal consulting firm was consulted for the retrospective review.This mdr is being filed based on the outcome of that retrospective review.

Event Description

Dealer stated that the gel packet came unglued from the base and rolled into a ball causing a pressure point on the end user's buttock.Skin was not broken, this was not a serious injury.However, left untreated, it has the likelihood of progressing to a serious injury; therefore, mdr is being filed.

• Brand Name: JAY UNION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93702 1328
• Manufacturer Contact: devin mcelroy ; 2842 n business park ave; fresno, CA 93702-1328
• MDR Report Key: 12318604
• MDR Text Key: 268023250
• Report Number: 9616084-2021-00041
• Device Sequence Number: 1
• Product Code: IMP
• UDI-Device Identifier: 00016958056402
• UDI-Public: 00016958056402
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAY UNION
• Device Catalogue Number: JAY
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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