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

Model Number LC358L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Head Injury (1879); Suture Abrasion (2497)

Event Date 01/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consumer's wife alleges her husband fell out of the chair and hit his head.

Event Description

Consumer's wife alleges her husband fell out of the chair and hit his head.

Manufacturer Narrative

The device was returned and evaluated.There was nothing physically or operationally defective with the lift chair that could be attributed to the alleged fall.- attachment: [5392 rpe signed.Pdf].

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa PA 18642
• MDR Report Key: 9569628
• MDR Text Key: 174463369
• Report Number: 2530130-2020-00003
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400244
• UDI-Public: 00606509400244
• Combination Product (y/n): N
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization