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

Model Number Q6 EDGE

Device Problems Entrapment of Device (1212); Unintended Collision (1429)

Patient Problem No Information (3190)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been made available for evaluation at this time.Should further information or the device become available for evaluation, a follow-up report will then be issued.

Event Description

Dealer alleges consumer was driving her powerchair up to the sink in the bathroom to rinse her toothbrush when the swing away swung away unexpectedly causing her to allegedly drive the chair into the shower and it got wedged under the sink.

Manufacturer Narrative

Only the swing away bracket was returned for evaluation.Although there are many unknown factors, it is the evaluator's opinion that the lack of witness marks on the swingaway bracket handle suggest the bracket was not tightened properly in the device's armrest which could have contributed to the alleged event.The joystick mount is assembled to the armrest by the provider/end-user.(b)(4).

Event Description

Dealer alleges consumer was driving her powerchair up to the sink in the bathroom to rinse her toothbrush when the swing away swung away unexpectedly causing her to allegedly drive the chair into the shower and it got wedged under the sink.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 182 susquehanna ave; n/a; exeter, PA 18643 ; 5706555574
• MDR Report Key: 5063582
• MDR Text Key: 25218192
• Report Number: 2530130-2015-00080
• Device Sequence Number: 1
• Product Code: ITI
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization