MAUDE Adverse Event Report: INVAMEX TREX2/WD66/ADULT/28/U550 9153637773; WHEELCHAIR, MECHANICAL

Model Number TRE26R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Dealer stated that the end user reported that her ac229403 bk amputee support that she is using on her trex26r wheelchair has caused a pressure sore on her right leg above the knee.Invacare called the dealer who stated that the attachment is rubbing the end user where the amputation is.No medical intervention was reported to the dealer by the end user, user just requested a different option since this one was rubbing.There is no malfunction of the product alleged, just that the users (amputated) leg is rubbing.Mdr filed based on the injury.

• Brand Name: TREX2/WD66/ADULT/28/U550 9153637773
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4625426
• MDR Text Key: 5658097
• Report Number: 9616091-2015-00788
• Device Sequence Number: 1
• Product Code: IOR
• 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: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRE26R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2015
• 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
• Patient Age: 62
• Patient Weight: 100