MAUDE Adverse Event Report: UNKNOWN FOOTREST W/AUMINUM FOOTPLATE AND HEEL LOOPS 9153650904; FOOTREST, WHEELCHAIR

Model Number T93HA

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Provider states they pulled a pair of the t93ha footrest out of stock and upon opening the box they noticed that both cam levers were cracked.

• Brand Name: FOOTREST W/AUMINUM FOOTPLATE AND HEEL LOOPS 9153650904
• Type of Device: FOOTREST, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4382874
• MDR Text Key: 20066183
• Report Number: 1525712-2014-08358
• Device Sequence Number: 1
• Product Code: IML
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T93HA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other