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

Model Number Q6 EDGE 2.0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The "date of event" has not been provided.The device has not been made available for evaluation at this time.Should further information or the device(s) become available, a follow-up report will be generated.

Event Description

Alleges the armrest snapped when he leaned on it to plug in his charger.Alleges bolt in the arm snapped and he fell out of chair and damaged a tooth.

Manufacturer Narrative

Only the arms were returned for evaluation.The adjustment screw on the flip up arm's turnbuckle assembly was fractured.The text of the complaint indicated the user was putting weight on the armrest (leaning).Pride warns against this action on pg.Twenty-one of the consumer safety guide : "warning! avoid putting all of your weight on the power chair armrests and do not use the armrests for weight bearing purposes, such as transfers.".

Event Description

Alleges the armrest snapped when he leaned on it to plug in his charger.Alleges bolt in the arm snapped and he fell out of chair and damaged a tooth.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 5706024056
• MDR Report Key: 7303900
• MDR Text Key: 101199429
• Report Number: 2530130-2018-00028
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200042
• UDI-Public: 00606509200042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 2.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization