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U.S. Department of Health and Human Services

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

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BLISS HEALTH PRODUCTS CO LTD DRIVE BED MANUAL Back to Search Results
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.
 
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Brand NameDRIVE
Type of DeviceBED MANUAL
Manufacturer (Section D)
BLISS HEALTH PRODUCTS CO LTD
61 & .96, zhaoyi rd
dongsheng town
zhongshan city, guangdong, 52841 4
CH 528414
MDR Report Key12685423
MDR Text Key281221187
Report Number2438477-2021-00064
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Number of Events Reported1
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 Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15201BV
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2021
Distributor Facility Aware Date09/29/2021
Device Age3 YR
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/22/2021 Patient Sequence Number: 1
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