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

Model Number Q6 EDGE 2.0

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem Physical Entrapment (2327)

Event Date 08/23/2015

Event Type  Injury  

Manufacturer Narrative

The device was evaluated and found to be user error.This is not a product issue.

Event Description

Customer alleges turning the chair to the left but too close to the wall and the rear of the chair turned right.The backpack bars hit his mother's arm and pinned it against the wall.The bar allegedly penetrated his mother's arm until she was able to release the clasp and slide arm off.

Manufacturer Narrative

The model number, serial number, and date of manufacture were updated.

Event Description

Customer alleges turning the chair to the left but too close to the wall and the rear of the chair turned right.The backpack bars hit his mother's arm and pinned it against the wall.The bar allegedly penetrated his mother's arm until she was able to release the clasp and slide arm off.

• 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: 5053574
• MDR Text Key: 24935980
• Report Number: 2530130-2015-00078
• 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
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 2.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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