MAUDE Adverse Event Report: CAREMED ULTRACARE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number ULTRACARE APL MATTRESS, ULTRACAR APL CU

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 10/10/2018

Event Type  Injury  

Event Description

Per (b)(6) the patient was found in the floor on both occasions and there were no injuries reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTRACARE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17532943
• MDR Text Key: 321107341
• Report Number: MW5139849
• 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: 11/14/2018

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: ULTRACARE APL MATTRESS, ULTRACAR APL CU
• Patient Sequence Number: 1