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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adult portable bed rails for medical purposes
Definition An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics.
Product CodeQTC
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 12 12
Insufficient Information 3 3
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Physical Entrapment 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Strangulation 2 2
Fall 2 2
Laceration(s) 2 2
Unspecified Musculoskeletal problem 1 1
Bone Fracture(s) 1 1
Crushing Injury 1 1
Post Traumatic Wound Infection 1 1
Insufficient Information 1 1
Airway Obstruction 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-05-2024
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