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

Model Number JAZZY 614HD

Device Problem Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 08/05/2015

Event Type  Death  

Manufacturer Narrative

This is not a product problem.Consumer's catheter became entangled in the wheel axle of the device.Pride warns in the consumer safety guide, "keep your hands, clothing and all other objects away from the tires when driving.Do not allow any personal belongings or objects to drag behind the scooter when driving.Be aware that loose fitting clothing or other objects can become caught in drive tires and/or they may become entangled in the running gear." (b)(4).

Event Description

Received fda medwatch program - mw5055843.Alleges consumer was in jazzy 614hd when the tubing from his foley catheter became tightly entangles in the right side wheel axle.

• 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: 5202378
• MDR Text Key: 30439835
• Report Number: 2530130-2015-00100
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY 614HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death