MAUDE Adverse Event Report: MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING; COMMODE CHAIR

Catalog Number DR-11148-4

Device Problem Failure to Align (2522)

Patient Problem Laceration(s) (1946)

Event Date 12/15/2014

Event Type  No Answer Provided  

Event Description

Pt purchased a 3-in-1 commode prior to discharge.They took it home and sat down to use and the seat was not properly aligned so the pt cut herself on her back side.

• Type of Device: COMMODE CHAIR
• Manufacturer (Section D): MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING; 99 seaview boulevard; port washington NY 11050
• MDR Report Key: 4486556
• MDR Text Key: 5563179
• Report Number: 4486556
• Device Sequence Number: 1
• Product Code: ILS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: DR-11148-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2015
• Event Location: Home
• Date Report to Manufacturer: 02/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES USED
• Patient Age: 90 YR
• Patient Weight: 52