Important Communication from the FDA
Non-Medline Bed Side Rail and Accessory use with Medline Homecare Beds
This communication is applicable to Medline Basic Homecare Beds, SKUs MDR107002E, MDR107002E-4, MDR107003E,
MDR107003E-4, and MDR107003ELO, and Medlite Homecare Beds, SKUs MDR107002L, MDR107003L, and MDR107003LO.
The purpose of this communication is to provide an important reminder regarding the proper use of bed side rails and accessories
with Medline Homecare Beds to ensure an optimal experience for end users. Medline Industries, LP has received information
through post-market surveillance regarding risk when using non-Medline side rails or accessories, specifically the use of some
non-Medline bed accessories may lead to patient injury or death.
Medline Industries, LP has received a total of (18) complaints that were related to misuse with a non-Medline side rail or bed
assist bar. The observed occurrence rate is 0.0025% across the distributed bed population.
This communication is a reminder to ONLY USE MEDLINE SIDE RAILS and MEDLINE ACCESSORIES that are intended for use with
Medline Homecare Beds. When using Medline Side Rails and Medline Accessories, follow all applicable instructions for use. DO
NOT USE non-Medline side rails or non-Medline accessories, including extension cords, with Medline Homecare Beds. The
following Medline Side Rail SKUs are compatible with both the Basic Homecare Beds and the Medlite Homecare Beds: MDS89697
(Clamp-On Half Rail), MDS89698N (Spring Loaded Half Rail), MDS89694N (Spring Loaded Full Rail), and MDS89695N (Economy Full
Rail).
Medline Homecare Beds have been rigorously tested and proven safe and effective when used in accordance with the Instructions
for Use provided with all Medline Homecare Beds.
Use of non-Medline bed side rails and accessories, including extension cords, with Medline Homecare Beds may result in serious
damage to bed or can cause patient injury or death.
