MAUDE Adverse Event Report: CAREMED BED, AC-POWERED ADJUSTABLE HOSPTIAL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 04/29/2020

Event Type  Injury  

Event Description

(b)(6) healthcare received the included information.The device(s) in question was not manufactured nor imported by (b)(6) healthcare, per section 803.22 (8) (2) we are submitting the following information.We are forwarding this information for further evaluation and processing.The manufacturer, care med, of the device involved in the attached incident was notified by (b)(6) on (b)(6) 2017.Unwitnessed fall with no injuries listed.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPTIAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17533439
• MDR Text Key: 321161067
• Report Number: MW5140343
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR