MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS DRIVE DEVILBISS HEALTHCARE PRIME CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by the end user's daughter who stated that the end user fell between the bed rails and bumpers onto the floor.It was unclear how the bed and accessories were assembled.The end user had bruising to their shoulder and a cut across their tear duct on the left eye.She went to the emergency room and had x-rays and a ct scan, and was prescribed an antibiotic cream for the cut across the tear duct.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE PRIME CARE BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS; 27-29 xinglin; north 2 road; xiamen, fujian ; CH
• MDR Report Key: 23831704
• Report Number: 2438477-2025-00071
• Device Sequence Number: 21090137
• Product Code: FNL
• UDI-Device Identifier: 00822383979434
• UDI-Public: (01)00822383979434
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025
• Report Date (Section F): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: P703
• Device Catalogue Number: P703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/09/2025
• Event Location: Home
• Date Report to Manufacturer: 12/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 12/17/2025