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

Model Number LC525IM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The "date of event" was not provided.The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.

Event Description

Alleges padding in arm is very little and has caused injury to ribs.

Manufacturer Narrative

(b)(4) rep confirmed nothing wrong with chair.Chair was in recline and the end user was leaning over to pick something up off the floor exposing here ribs to a portion of the chair that does not have padding.Rep has given her a set of arm covers so padding can be added and used when chair is in full recline.

Event Description

Alleges padding in arm is very little and has caused injury to ribs.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: 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 ; 5706024056
• MDR Report Key: 8884137
• MDR Text Key: 154105953
• Report Number: 2530130-2019-00096
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400107
• UDI-Public: 00606509400107
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: LC525IM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization