MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE LIMITED BED; BED, MANUAL

Model Number 15005LP

Patient Problem Bruise/Contusion (1754)

Event Date 08/29/2022

Event Type  Injury  

Event Description

(b)(6) stated that railing was not attached properly to frame and came off bed.The railing came and hit her on the leg and was left with a black and blue bruise.She now has a stool over equipment so no one walks into equipment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED
• Type of Device: BED, MANUAL
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE LIMITED
• MDR Report Key: 17567350
• MDR Text Key: 321551079
• Report Number: MW5144698
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15005LP
• Patient Sequence Number: 1
• Patient Sex: Female