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

Model Number	LC358XXL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Provider alleges consumer alleges that the back of the chair has snapped off and allegedly threw her back out of the chair.
Event or Problem Description
Provider alleges consumer alleges that the back of the chair has snapped off and allegedly threw her back out of the chair.
Additional 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
• Common Device Name: 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
• Report Number: 2530130-2021-00129
• Device Sequence Number: 4616805
• Product Code: INO
• UDI-Device Identifier: 00606509400305
• UDI-Public: 00606509400305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female