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

Model Number LC358PW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consumer's daughter alleges there is no stuffing in the seat and you can feel the wood which is allegedly giving her mom sores.

Manufacturer Narrative

The device was returned and evaluated.The complaint could not be substantiated.The seat had foam and no wood was felt.

Event Description

Consumer's daughter alleges there is no stuffing in the seat and you can feel the wood which is allegedly giving her mom sores.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11223842
• MDR Text Key: 228477330
• Report Number: 2530130-2021-00008
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400275
• UDI-Public: 00606509400275
• Combination Product (y/n): N
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358PW
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization