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

Model Number CAREMED 35X84 ULTRACARE APL MATTRESS, APL CONTROL UNIT

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 12/15/2018

Event Type  Injury  

Event Description

Residence heard calling out for staff.Went to investigate and notice resident lying on the left side of the bed on the floor.Skin tear to right knee.Vital sign within normal limit.Respiration even and unlabored.Resident said hes not hurt.Resident said he was slowly sliding for awhile and eventually fell onthe floor.Dr.(b)(6) was on call, new order for steri strip to right knee.Monitor every shift and family is aware.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: 17531080
• MDR Text Key: 321136343
• Report Number: MW5137997
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CAREMED 35X84 ULTRACARE APL MATTRESS, APL CONTROL UNIT
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 30 YR