MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION INC MEDICHOICE COMMODE

Catalog Number 2867 COMM6002

Device Problem Material Deformation (2976)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 08/09/2016

Event Type  malfunction  

Event Description

When sitting down on bedside commode, the seat pinched the pt's right inner thigh.This occurred multiple times resulting in bruising and bleeding to the skin.

• Brand Name: MEDICHOICE COMMODE
• Type of Device: COMMODE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION INC; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 5895935
• MDR Text Key: 52762742
• Report Number: 5895935
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2867 COMM6002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 70