MAUDE Adverse Event Report: INVACARE CLEVELAND STREET INVACARE MATRX FLOVAIR GENTLE CONTOUR 18X18; CUSHION, WHEELCHAIR

Model Number ITFG

Device Problem Break (1069)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

Dealer reported that the foam in an itfg "in touch" cushion is compressed in the middle rear and the overlay is sliding off the foam causing the zipper to break.Bladder inside is not broken.The end user is allegedly getting a pressure sore on their lower right buttock, stage 2 pressure ulcer.End user reported that this is the first pressure sore and he has been in and out of hospital with the issue.

• Brand Name: INVACARE MATRX FLOVAIR GENTLE CONTOUR 18X18
• Type of Device: CUSHION, WHEELCHAIR
• Manufacturer (Section D): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer (Section G): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4562228
• MDR Text Key: 5557799
• Report Number: 1219590-2015-00051
• Device Sequence Number: 1
• Product Code: IMP
• 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: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ITFG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• 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): Other