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

Catalog Number MDR107002E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Electric Shock (2554)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2023 the staff member "was changing a client and stepped on a cord connected to bed when a shock went up my leg from my foot to my leg".Per the facility the provider was unaware of the exposed wire prior to use and did not incur a serious injury or require medical attention.No additional information is available.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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

According to the facility on (b)(6) 2023 the staff member "was changing a client and stepped on a cord connected to bed when a shock went up my leg from my foot to my leg".

Manufacturer Narrative

Updated: b4, d9, g6, h2, h3, h6.

• 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: 18455165
• MDR Text Key: 332254837
• Report Number: 1417592-2024-00012
• 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,Followup
• Report Date: 04/04/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other