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

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.

• Brand Name: PROBASICS
• Type of Device: HALF LENGTH BED RAILS
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.96, zhaoyi rd.; dongsheng town; zhongshan city guangdong, ; CH
• MDR Report Key: 7472413
• MDR Text Key: 106875315
• Report Number: 3012316249-2018-00024
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• 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 Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PB7035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2018
• Distributor Facility Aware Date: 04/06/2018
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR
• Patient Weight: 54