MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number	JAZZY ELITE ES
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.
Event or Problem Description
Customer alleges she sustained an injury while seated in her power chair.Customer alleges her clothing accidentally got caught on the joystick when the power chair was left on resulting in sudden unintended movement causing the customer to forcibly strike the metal frame of the hospital bed in her room at warren barr.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10178875
• Report Number: 2530130-2020-00059
• Device Sequence Number: 3599953
• Product Code: ITI
• UDI-Device Identifier: 00606509100083
• UDI-Public: 00606509100083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: JAZZY ELITE ES
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization