MAUDE Adverse Event Report: AMERICAN NATIONAL MATTRESS , AIR FLOATION, ALTERNATING PRESSURE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 7300-SB100LE-3580

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 03/09/2019

Event Type  Injury  

Event Description

On saturday this patient fell from his bed and dislocated his hip.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS , AIR FLOATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): AMERICAN NATIONAL
• MDR Report Key: 17535700
• MDR Text Key: 321136193
• Report Number: MW5142595
• Device Sequence Number: 1
• Product Code: FNM
• 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: 03/28/2019

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
• Device Model Number: 7300-SB100LE-3580
• Patient Sequence Number: 1