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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. PROBASICS HALF LENGTH BED RAILS

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BLISS HEALTH PRODUCTS CO., LTD. PROBASICS HALF LENGTH BED RAILS Back to Search Results
Model Number PB7035
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Fracture, Arm (2351)
Event Date 03/28/2018
Event Type  Injury  
Event Description
Per the daughter, she placed the patient in bed, at home, and she did not put the side rails up. She returned to the room and found the patient on the floor. Patient was transported to the hospital via paramedics due to a visible left arm fracture.
 
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Brand NamePROBASICS
Type of DeviceHALF LENGTH BED RAILS
Manufacturer (Section D)
BLISS HEALTH PRODUCTS CO., LTD.
no.96, zhaoyi rd.
dongsheng town
zhongshan city guangdong,
CH
MDR Report Key7472413
MDR Text Key106875315
Report Number3012316249-2018-00024
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPB7035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2018
Distributor Facility Aware Date04/06/2018
Device Age10 MO
Event Location Home
Date Report to Manufacturer04/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/30/2018 Patient Sequence Number: 1
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