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

Model Number Q6 EDGE 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

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.

Event Description

Provider alleges consumer alleges he hasn't been able to use the chair for a few weeks since the switching motor was allegedly stuck between the posterior and anterior position.He has since allegedly developed a stage 2 pressure injury.He alleged the wound got more concerning because he wasn't able to tilt or recline since it got stuck in anterior.

Manufacturer Narrative

Tilt and recline functions were operational.

Event Description

Provider alleges consumer alleges he hasn't been able to use the chair for a few weeks since the switching motor was allegedly stuck between the posterior and anterior position.He has since allegedly developed a stage 2 pressure injury.He alleged the wound got more concerning because he wasn't able to tilt or recline since it got stuck in anterior.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18344 ; 8008008586
• MDR Report Key: 18621472
• MDR Text Key: 334308880
• Report Number: 2530130-2023-00312
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200158
• UDI-Public: 00606509200158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143383
• 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: 01/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male