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 Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

The exact "date of event" is unknown.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 staples are coming out of footrest and are tearing customer's heels.

Manufacturer Narrative

The technician disposed of the device in error.Therefore, the device was not returned to pride and no evaluation could take place.

Event Description

Alleges staples are coming out of footrest and are tearing customer's heels.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; n/a; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; n/a; duryea, PA 18642 ; 5706555574
• MDR Report Key: 7177818
• MDR Text Key: 96810948
• Report Number: 2530130-2018-00004
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400244
• UDI-Public: 00606509400244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization