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

Catalog Number G30210-4F

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Date 05/02/2019

Event Type  malfunction  

Event Description

Fall without injury, defective bedside commode.Leg bent while pt sitting on bedside commode.

• Brand Name: GUARDIAN SIGNATURE
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8836051
• MDR Text Key: 152492201
• Report Number: 8836051
• Device Sequence Number: 1
• Product Code: ILS
• 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: 07/08/2019,05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: G30210-4F
• Device Lot Number: 6451704000
• 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: 07/08/2019
• Date Report to Manufacturer: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA