MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

Model Number GL358PWKD

Device Problem Unintended System Motion (1430)

Patient Problem Injury (2348)

Event Date 06/13/2014

Event Type  Injury  

Event Description

Customer alleges the back of the chair drops back 4 to 5 inches when reclining and has caused her a shoulder injury.

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 issued.

Event Description

Customer alleges the back of the chair drops back 4 to 5 inches when reclining and has caused her a shoulder injury.

Manufacturer Narrative

The device was returned and evaluated.The alleged condition could not be duplicated.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• 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: 3922790
• MDR Text Key: 20265375
• Report Number: 2530130-2014-00048
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GL358PWKD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2014
• 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