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

Model Number	JAZZY EVO 613
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges that he has been waiting for new elr's.The consumer has a single right leg amputation and also has severe edema.He is alleging that from not having the elr's he allegedly has swelling, blisters and now abscesses.
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea 18344
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18642 ; 8008008586
• MDR Report Key: 17611633
• Report Number: 2530130-2023-00142
• Device Sequence Number: 15111165
• Product Code: ITI
• UDI-Device Identifier: 00606509100281
• UDI-Public: 00606509100281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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 EVO 613
• 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: 08/18/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose