MAUDE Adverse Event Report: INVAMEX TREX2/WD86/ADULT/28/BH16/1255/U2222C/COM/U550 9153637774; WHEELCHAIR, MECHANICAL

Model Number TREX28R

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.User¿s manual review 1110546 rev.H.(page 11) if so equipped, anti-tippers must be attached at all times.Inasmuch as the anti-tippers are an option for 0° or 3° on this wheelchair (you may order with or without the anti-tippers), invacare strongly recommends ordering the anti-tippers as a safeguard for the wheelchair user.(page 24) every six months or as necessary, take your wheelchair to a qualified technician for a thorough inspection and servicing.Regular cleaning will reveal loose or worn parts and enhance the smooth operation of your wheelchair.To operate properly and safely, your wheelchair must be cared for just like any other vehicle.Routine maintenance will extend the life and efficiency of your wheelchair.

Event Description

The end user stated he kept tipping backwards in his chair and at one point, he fell and he cracked three of his ribs.End user made it sound like there was a second chair, but the nurse explained that it was the same chair that he was using and there are no anti tippers on the chair, and she explained he is a large gentleman and he "plops" into the chair.The incident was supposedly a long time ago and the customer is fully recovered.No further information provided.Update from 02/08/2016 added by consumer affairs: end user has no recent injuries with the chair but is very hard on the chair and plops down.No further information provided at this time.

• Brand Name: TREX2/WD86/ADULT/28/BH16/1255/U2222C/COM/U550 9153637774
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 88780 ; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5429915
• MDR Text Key: 38008242
• Report Number: 9616091-2016-00192
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2016

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: TREX28R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 02/11/2016
• 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): Hospitalization