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

Model Number GL358XL/LC358XL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider alleges the consumer alleges he was reclined in the chair and the remote's lights allegedly flashed on and off he did not think any thing of it but then while talking with his brother; sparks allegedly started to come out of the remote as he was repositioning the chair to be more comfortable, consumer alleges he was in a panic and his brother told him to roll or slid out of it which he slid down and rolled off it.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: CHAIR, ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18344 ; 8008008586
• MDR Report Key: 18815257
• MDR Text Key: 336621803
• Report Number: 2530130-2024-00334
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GL358XL/LC358XL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male