MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PENDANT FOR MDR107003E

Catalog Number MDR520094

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer "their father was holding the bed remote control while lying in bed when it ignited in smoke and flames and the remote became engulfed in a flame while in their hand".Per the customer "their father's fingertips were hurting him because they had been singed".Per the customer the fire and smoke were coming from the back of the remote control.Per the customer they contacted their home healthcare nurse who used a cold wet towel on the impacted area.The device has been in use for 4 years and is used daily.The device was purchased from orbit supply company.The device has been requested for evaluation.No additional information is available at this time.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 customer "their father was holding the bed remote control while lying in bed when it ignited in smoke and flames and the remote became engulfed in a flame while in their hand.".

Manufacturer Narrative

Updated: d2, d4, g6, h2, h6.

• Type of Device: PENDANT FOR MDR107003E
• 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: 17572425
• MDR Text Key: 321425547
• Report Number: 1417592-2023-00347
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDR520094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• 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): Other