MAUDE Adverse Event Report: INVAMEX 9SL/WD86/78/BH1517/ADULT/15P/AT903/U2222/COM/U240; WHEELCHAIR, MECHANICAL

Model Number 9SL

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned.Per the returns plan in oracle unit returned on 06/19/2014.Evaluation shows both seat rails are bent.Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Per provider, the bar that seat upholstery bolts to is bent.

• Brand Name: 9SL/WD86/78/BH1517/ADULT/15P/AT903/U2222/COM/U240
• 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: 5747579
• MDR Text Key: 48116429
• Report Number: 9616091-2016-00937
• 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: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• 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