MAUDE Adverse Event Report: INVAMEX TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number TRSX5

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

Event Description

The dealer states that the composite part of the wheel appears very choppy cut and has potential injury if used.Per the technician's evaluation, the composite wheels have burrs on them.

Manufacturer Narrative

Additional/updated information was added to reflect the device receiving an expanded evaluation.The result of the evaluation was that inspection of the wheelchair's push-rim wheels found flashing on both sides of the inner wheel rim on both wheels, along with residual burrs and injection molding gate bases, which confirmed the complaint of the wheels appearing "choppy".Both wheels appeared to have not been properly deburred.The plastic burrs were all small and relatively dull.The molding gate bases were qualitatively analyzed for sharpness by passing a gloved finger over each in both directions multiple times.In each test, the glove material did not cut, tear, or abrade despite pressing forcefully, so it is unlikely that any of the molding gates or burrs could have easily caused a cut injury.They also did not impact the functionality of the wheels.

Event Description

The dealer states that the composite part of the wheel appears very choppy cut and has potential injury if used.Per the technician's evaluation, the composite wheels have burrs on them.Per the expanded evaluation report, inspection of the wheelchair's push-rim wheels found flashing on both sides of the inner wheel rim on both wheels, along with residual burrs and injection molding gate bases, which confirmed the complaint of the wheels appearing "choppy".Both wheels appeared to have not been properly deburred.The plastic burrs were all small and relatively dull.The molding gate bases were qualitatively analyzed for sharpness by passing a gloved finger over each in both directions multiple times.In each test, the glove material did not cut, tear, or abrade despite pressing forcefully, so it is unlikely that any of the molding gates or burrs could have easily caused a cut injury.They also did not impact the functionality of the wheels.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• 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: 5269988
• MDR Text Key: 33011591
• Report Number: 9616091-2015-02815
• 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,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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