MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GUARDIAN BEDSIDE COMMODE; ADAPTOR, HYGIENE

Catalog Number MDS89664

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Event Description

Pt assisted to commode.After pt got up from commode with assistance and placed back in bed, rn noticed that the commode's front legs were bent in.Weight limit of commode 350 pounds, pt's weight 273 pounds.Fda safety report id# (b)(4).

• Brand Name: GUARDIAN BEDSIDE COMMODE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8960682
• MDR Text Key: 156766780
• Report Number: MW5089538
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS89664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• 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 Age: 67 YR
• Patient Weight: 124