Medline updates recall on all bed-related products as reported deaths climb
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Medical device maker Medline updated the information related to the recall of all its beds and bed accessories, reporting even more deaths and serious injuries linked to its products and offering customers details on what to do with the products.
Big picture view:
Customers were first alerted to the recall in mid-October, and the company issued an Urgent Medical Device Field Safety notice covering every bed, bedrail, mattress, and accessory produced over the past 15 years. In its notice to the FDA, Medline also stated that the products were discontinued, and it was leaving the market.
Why you should care:
In an Oct. 20 alert on the FDA website, Medline reported that the company was aware of two deaths and 16 serious injuries connected to its products, which were sold to durable medical equipment providers and long-term care facilities, as well as directly to customers. By Nov. 8, less than three weeks later, those numbers had grown to seven reported deaths and 35 related serious injuries.
The backstory:
The recall stems from a potential fire hazard and the risk of a person becoming trapped. It also provides new information on how users can repair, replace, or get a full or partial refund on the products. The alert states that the more than 1,000 Medline brand beds, associated rails, mattresses, and accessories on the market are included in the recall. The full list of affected products are available here.
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What's next:
Medline followed the original notice that was mailed to customers with one dated Oct. 24 that provided instructions for how to continue using the products and let them know about their options of getting the product repaired, replaced, or refunded. The updated steps for continued use is available here.
The company’s notice states that some beds may be eligible for repair or, if they cannot be fixed, replacement. Customers who need to check on their eligibility status are advised to contact the provider or distributor from which the product was purchased. Those who bought their items directly from Medline should call Medline Recall Customer Service at 800-950-0128, option 7. Customers with questions about the recall can also call that number between the hours of 8 a.m. and 5 p.m. CT Monday through Friday.
What you can do:
The FDA recommends that anyone who suffered adverse reactions or quality problems related to the beds, mattresses, or accessories reach out to its MedWatch Adverse Event Reporting program.
Online reports can be made at this website. A downloadable form that can be mailed to the agency is available online or can be requested by calling 800-332-1088.
The Source: Information for this article was taken from the Food and Drug Administration. This story was reported from Orlando, Florida.