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

Model Number LC575

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 09/08/2014

Event Type  Injury  

Event Description

The consumer is alleging the fabric on his chair is so slippery that he slides out of it.He's alleging he slid onto floor.He is unable to use the chair.

Manufacturer Narrative

A field service technician replaced the device with a new device that has a different type of fabric.The unit is working properly.

Event Description

The consumer is alleging the fabric on his chair is so slippery that he slides out of it.He's alleging he slid onto floor.He is unable to use the chair.

Manufacturer Narrative

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

• 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; exeter, PA 18643 ; 5706555574
• MDR Report Key: 4090558
• MDR Text Key: 5212018
• Report Number: 2530130-2014-00069
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: LC575
• 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
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• 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