MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO LTD DRIVE; BED MANUAL

Model Number	15201BV
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Eye Injury (1845); Fall (1848)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a hospital bed.The device has not been returned for evaluation.We will be filing a follow-up when additional information is available.We are submitting this report in an overabundance of caution and to be timely.The end-user is nonverbal.While under caregiver supervision the occupant fell out of the device.She landed face down and hit her eye.She sustained a bump on her eye.They were waiting for the doctor to do an x ray and make sure everything was ok.A follow-up visit is expected from the doctor.The caregiver believes that a piece, a screw, is missing off the rail on one side of the device.She is unaware of when this piece became missing.She is seeking reimbursement for the repairs of the unit and a technician coming.

• Brand Name: DRIVE
• Common Device Name: BED MANUAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO LTD; 61 & .96, zhaoyi rd; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 12685423
• Report Number: 2438477-2021-00064
• Device Sequence Number: 1231486
• Product Code: FNJ
• UDI-Device Identifier: 00822383143361
• UDI-Public: 822383143361
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2021
• Report Date (Section F): 10/22/2021

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: Health Professional
• Device Model Number: 15201BV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/29/2021
• Device Age: 3 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2021
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86
• Date Report Sent to FDA: 10/22/2021