MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GUARDIAN COMMODE; ATTACHMENT, COMMODE, WHEELCHAIR

Catalog Number MDS89664A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Skin Tears (2516)

Event Date 07/08/2021

Event Type  malfunction  

Event Description

Occupational therapist and ot tech notified writer of new skin tear on pt's l posterior thigh.Upon assessment with ot, both writer and therapist noticed bedside commode w/ dry blood on left side of bar below seat w/ screw protruding out to where it could contact pt's leg.Writer and ot inferred that commode caused left posterior thigh skin tear.

• Brand Name: GUARDIAN COMMODE
• Type of Device: ATTACHMENT, COMMODE, WHEELCHAIR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 12226990
• MDR Text Key: 263513657
• Report Number: 12226990
• Device Sequence Number: 1
• Product Code: INB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS89664A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22630 DA
• Patient Weight: 72