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

Model Number	LC358M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
Consumer alleges she was not told how to use the unit and she allegedly ripped skin off of her already injured feet.She also alleges she reinjured a spinal injury.
Event or Problem Description
Provider alleges consumer was lowering the footrest when he allegedly sustained a shock from his thumb (which was on the down button on the remote) that travelled up his arm.
Additional Manufacturer Narrative
Evaluated by provider: provider reported no issues with electrical or operation of the chair.

• 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: 13792122
• Report Number: 2530130-2022-00020
• Device Sequence Number: 17070578
• Product Code: INO
• UDI-Device Identifier: 00606509400251
• UDI-Public: 00606509400251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/24/2022

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: LC358M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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: Male