MAUDE Adverse Event Report: SLEEPSAFE BEDS SLEEPSAFE BED; SAFETY BED

Device Problem Mechanical Problem (1384)

Patient Problem Skin Tears (2516)

Event Date 10/14/2022

Event Type  Injury  

Event Description

Home health nurse closed safety rail on (b)(6) finger.This is a 'special needs' safety bed and users finger was injured requiring medical care.

• Brand Name: SLEEPSAFE BED
• Type of Device: SAFETY BED
• Manufacturer (Section D): SLEEPSAFE BEDS; 3629 reed creek drive; bassett VA 24055
• MDR Report Key: 15797415
• MDR Text Key: 303639500
• Report Number: 3008061384-2022-22474
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic