MAUDE Adverse Event Report: DRIVE MEDICAL SHOWER BENCH GREY; ADAPTOR HYGIENE

Model Number RTL 12203KDR

Device Problems Crack (1135); Product Quality Problem (1506); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 09/24/2017

Event Type  Injury  

Event Description

I purchased a drive shower bench grey that holds weight up to 400 pounds.While using in shower the seat started going toward my glass shower doors, so i immediately got up and started to check the aluminium legs that hold the weight of the bench are leaning sideways, and noticed cracks in the aluminium where the bolts attach up under the seat.I am around (b)(6) and the seat is supposed to hold up to 400.This could have been bad if i would have gone through the glass shower doors.Chair purchased for non weight bearing surgery.

• Brand Name: SHOWER BENCH GREY
• Type of Device: ADAPTOR HYGIENE
• Manufacturer (Section D): DRIVE MEDICAL
• MDR Report Key: 6903649
• MDR Text Key: 87872764
• Report Number: MW5072537
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL 12203KDR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 100