MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number SC60

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 01/04/2015

Event Type  Injury  

Event Description

Customer alleges riding his scooter when the seat post broke and he fell and hit a wall.Called 911 for assistance to get up.Did not seek medical treatment.

Manufacturer Narrative

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

Event Description

Customer alleges riding his scooter when the seat post broke and he fell and hit a wall.Called 911 for assistance to get up.Did not seek medical treatment.

Manufacturer Narrative

A field service technician replaced the seat.The device is working properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; 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: 4456084
• MDR Text Key: 17995567
• Report Number: 2530130-2015-00013
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC60
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2010
• 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