MAUDE Adverse Event Report: UNKNOWN VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND ELEV LEGRESTS; WHEELCHAIR, MECHANICAL

Model Number V18PFR

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

(b)(4).- should additional information become available, a supplemental record will be filed.

Event Description

Caller stated seat upholstery stretched out to the point where seat was getting close to touching cross brace and end user had pressure on his hips and right leg because of sagging.Update by consumer affairs: dealer replaced chair.Seat was sagging slightly but not torn.No confirmation that the sag caused the leg pain.Dr stated it was muscle soreness.

• Brand Name: VERANDA 18 IN X 16 IN FRAME W/FULL LENGTH PERM ARMS AND ELEV LEGRESTS
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5107529
• MDR Text Key: 26884154
• Report Number: 1525712-2015-04660
• Device Sequence Number: 1
• Product Code: ITJ
• 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
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V18PFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• 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): Required Intervention
• Patient Age: 83
• Patient Weight: 118