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

Model Number PB7035

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient reports he grabbed the left side rail for assist with position change and the rail fell off the bed causing him to fall out of the bed also.While on the floor the patient noted blood on his left foot.Looking at the left foot there is a laceration, approximately 1.5 x 0.5 cm on the bottom side of the foot between the 3rd and 4th toes.The patient was unable to stop the bleeding and neither was the nurse.The patient went to the hospital where 2 deep tissue sutures were used to close the wound.Patient was kept at the hospital for observation due to low hgb, the hgb dropped from 9.9 down to 7.5.Patient had blood testing (type and cross) for possible transfusion.The bed the patient was in is an invacare model 5301low with serial number (b)(4).The end-users bed and rails were replaced on the 18th.Unknown if replaced before or after incident.The instructions for the bed rails state on page 4, the second "warning", states the following: do not use the clamp-on rail as a handle for getting into or out of bed; this could result in personal injury and damage to the clamp-on rail.Caution: do not exert side pressure on the clamp-on half rail; this could deform or break it.Caution: do not use the clamp-on half rail as a push handle for moving the bed; this could deform or break it.

• 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: 10276638
• MDR Text Key: 200381929
• Report Number: 3012316249-2020-00022
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/15/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: PB7035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Distributor Facility Aware Date: 06/24/2020
• Event Location: Home
• Date Report to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91