MAUDE Adverse Event Report: DRIVE MEDICAL, CANADA, INC. DRIVE MEDICAL DROP ARM COMMODE; ADAPTER, HYGIENE

Model Number 11125-KD-1

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/22/2018

Event Type  malfunction  

Event Description

Drop arm commode toilet seat pops off when performing slide board transfers.This is very unsafe due to danger of slide board falling off device thus being a high risk for pt falls and/or injury.

• Brand Name: DRIVE MEDICAL DROP ARM COMMODE
• Type of Device: ADAPTER, HYGIENE
• Manufacturer (Section D): DRIVE MEDICAL, CANADA, INC. ; 99 seaview blvd; port washington NY 11050
• MDR Report Key: 8038079
• MDR Text Key: 126283664
• Report Number: MW5081045
• 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: Occupational Therapist
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11125-KD-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 79