MAUDE Adverse Event Report: INVAMEX TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565; WHEELCHAIR, MECHANICAL

Model Number TRSX58FBFP

Device Problems Break (1069); Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Event Description

Dealer reported that the arm pad vinyl on a trsx58fbfp wheelchair is breaking (cracking), causing irritation to the end user's arms.The dealer states it is from the user constantly using the arms to readjust the way he is siting.This is a cosmetic defect condition that does not affect the form, fit or function of this device.There is no allegation of a serious injury or medical intervention alleged.Mdr filed based on the injury.

• Brand Name: TRSX5/WD86/ADULT/18FB/BH16/1255/U2222C/U240 9153653565
• 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: 4680211
• MDR Text Key: 5643927
• Report Number: 9616091-2015-01010
• Device Sequence Number: 1
• Product Code: CAW
• 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: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX58FBFP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/10/2015
• 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): Other