MAUDE Adverse Event Report: INVAMEX FOLDING SHOWER CHAIR W/BACK 9153634972; ADAPTOR, HYGIENE

Model Number 9981

Device Problem Bent (1059)

Patient Problem Fall (1848)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It has been reported by an end user that an (b)(4) shower chair has collapsed, causing them to fall to the shower floor.Additionally, the left rear leg of the chair is now bent.

• Brand Name: FOLDING SHOWER CHAIR W/BACK 9153634972
• Type of Device: ADAPTOR, HYGIENE
• 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: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4384327
• MDR Text Key: 17263147
• Report Number: 9616091-2014-02634
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2014
• 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