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

Model Number LC358XXL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider alleges consumer alleges that the back of the chair has snapped off and allegedly threw her back out of the chair.

Event Description

Provider alleges consumer alleges that the back of the chair has snapped off and allegedly threw her back out of the chair.

Manufacturer Narrative

The 4mm thick steel kd bracket was torn at the offset on both sides.This damage was more severe on the right side.The wooden frame was fractured at the upper left corner of the seat box where the kd bracket attaches.This type of extreme damage would be consistent with customer misuse.(downward force on seat back) the 358xxl was tested in 2017 at a cyclical load weight of 660lbs and a static load weight of 900lbs.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 12909191
• MDR Text Key: 281516583
• Report Number: 2530130-2021-00129
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400305
• UDI-Public: 00606509400305
• 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,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358XXL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2021
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: Female