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

Model Number 15201BV

Device Problem Device Damaged Prior to Use (2284)

Patient Problems Eye Injury (1845); Fall (1848)

Event Date 09/29/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 281221187
• Report Number: 2438477-2021-00064
• Device Sequence Number: 1
• Product Code: FNJ
• UDI-Device Identifier: 00822383143361
• UDI-Public: 822383143361
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/22/2021,10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15201BV
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2021
• Distributor Facility Aware Date: 09/29/2021
• Device Age: 3 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86