MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BED,BASIC, SEMI ELECTRIC

Catalog Number MDR107002E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 01/29/2024

Event Type  Injury  

Event Description

According to the customer on (b)(6) "the remote has a shortage, the wire is showing, you have to hold it a certain way".

Manufacturer Narrative

According to the customer on (b)(6) "the remote has a shortage, the wire is showing, you have to hold it a certain way".Per the customer they were "trying to sit up and the remote stopped working" and when the customer went to "lean to look at remote" they fell out of the bed.Per the customer they called emergency medical services "blood was everywhere, my head was busted, had to get staples".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18748387
• MDR Text Key: 335933977
• Report Number: 1417592-2024-00082
• Device Sequence Number: 1
• Product Code: LLI
• 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: 02/21/2024

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 Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other