MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE; MECHANICAL WHEELCHAIR

Model Number QUICKIE 2

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

Patient Problems Abrasion (1689); Rupture (2208)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Dealer reports that the end user allegedly injured her leg.The dealer reports the end user has severe dementia and skin that is susceptible to breakdown.The end user's daughter stated that while transferring from the toilet to the wheelchair, the end user hit her left leg on the receiver where the hangers would typically be attached.There were no footplates attached to the wheelchair during the time of transfer because the end user's daughter stated that the footplates were not typically used inside of the house.The end user's daughter stated the end user was admitted into the hospital for 5 days after the reported incident.The end user's daughter stated that she was told that the wound was considered to be "stage 4" and did not require stitches.The wheelchair is currently in the dealer's possession.

Manufacturer Narrative

Background information: quickie 2 wheelchair owner's manual, page 10 states: "before transferring: 1.Flip-back or remove the armrests.2.Swing-away or remove the footrests.3.Make sure the wheel lock is set." quickie 2 wheelchair owner's manual, page 10 states: "it is dangerous to transfer on your own.It requires good balance and agility.Be aware that there is a point during every transfer when the wheelchair seat is not below you.To avoid a fall: 7.If you can, remove the footrests, or swing them out of the way.A.Make sure your feet do not catch in the space between the footrests.B.Avoid putting weight on the footrests as this may cause the chair to tip." discussion: in evaluating the complaint, the dealer reports that the end user allegedly injured her leg.The end user's daughter states that while transferring from the toilet to the wheelchair, the end user hit her left leg on the receiver where the hangers would typically be attached.There were no footplates attached to the wheelchair during the time of transfer because the end user's daughter stated that the footplates were not typically used inside of the house.Another potential reason the footplates were not being utilized is because according to the quickie 2 wheelchair owner's manual, "i.Transfers.Before transferring: 2.Swing-away or remove footrests." there is no evidence of malfunction or defect from the wheelchair.The wheelchair is currently in the dealer's possession.There has been no indication that the wheelchair would be returned to sunrise medical for evaluation.The end user's daughter stated the end user was admitted into the hospital for 5 days after the reported incident.The end user's daughter stated that she was told that the wound was considered to be "stage 4" and did not require stitches.The dealer reported that the end user's skin is susceptible to breakdown, which could potentially be the cause of the wound's alleged severity.The end user's daughter stated that the end user gets daily wound care treatment.The wound care specialist stated that the wound had an infection at one point and the wound is taking time to heal.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.Conclusion: in conclusion, there is no evidence of malfunction or defect from the wheelchair.Due to the allegation of a serious injury that required hospitalization (stage 4 wound on left leg), this mdr is being filed.

• Brand Name: QUICKIE
• Type of Device: MECHANICAL WHEELCHAIR
• 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: 19093341
• MDR Text Key: 339982785
• Report Number: 9616084-2024-00008
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958043815
• UDI-Public: 00016958043815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE 2
• Device Catalogue Number: EIQ2X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2024
• 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): Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 57 KG