MAUDE Adverse Event Report: UNKNOWN BED ASSIST BAR

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Entrapment (2327)

Event Date 12/12/2020

Event Type  Death  

Manufacturer Narrative

It was reported by the u.S.Consumer product safety commission that an (b)(6) female fell off of the side of her bed resulting in her neck getting caught between the bed assist bar and the bed.The report stated that the customer became entangled in a retail purchased bed rail installed by her son at her home.According to the report the device was purchased at the local walmart store and was new in the box.The initial report in 2020 did not identify a product code, however the son later identified a product code in 2022 via an instructions for use document which was later attached to the police investigation.It is unknown how the product code was identified or where the document was obtained from.The photographs from the police investigation were obtained by the suspected manufacturer, however, after evaluation of the photographs this manufacturer is unable to confirm the device in the photographs is manufactured by this company.The product could not be further identified and the manufacturer is unknown.The medical examiner's report indicated the cause of death as positional asphyxia and the manner of death as accidental.No additional information is available.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the end-user caught her neck in the bed assist bar and passed away.

• Brand Name: BED ASSIST BAR
• Type of Device: BED ASSIST BAR
• Manufacturer (Section D): UNKNOWN
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14436835
• MDR Text Key: 292038676
• Report Number: 1417592-2022-00065
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 67 KG