MAUDE Adverse Event Report: SAME SLEEPSAFE BED; SAFETY BED

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/11/2019

Event Type  Injury  

Event Description

User (child) crawled over safety rail.The user fell and fractured wrist.The safety bed is in a private home and is "second-hand." the parent is ordering an extension to provide the proper safety configuration based on the child's needs and abilities.

• Brand Name: SLEEPSAFE BED
• Type of Device: SAFETY BED
• Manufacturer (Section G): SAME; same; same,
• Manufacturer Contact: robert baldacci ; 3629 reed creek drive; bassett, VA 24055 ; 8668522337
• MDR Report Key: 8804069
• MDR Text Key: 151482318
• Report Number: 3008061384-2019-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention