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

Model Number PLR2985M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consumer's wife alleges the chair allegedly threw her husband out of it and called 911 to help him up.

Event Description

Consumer's wife alleges the chair allegedly threw her husband out of it and called 911 to help him up.

Manufacturer Narrative

Spoke with consumer's wife.She researched the chairs.They need the leather and she stated there are no other chairs that her husband can use.They are very grateful to pride but they are going to keep the chair they have.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 9738198
• MDR Text Key: 190606141
• Report Number: 2530130-2020-00028
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401289
• UDI-Public: 00606509401289
• Combination Product (y/n): N
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR2985M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization