MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PENDANT FOR MDR107002E

Catalog Number MDR510094

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2023

Event Type  Injury  

Event Description

According to the customer, they smelled "smoke" in the house and found the pendant "smoking and hot.".

Manufacturer Narrative

According to the customer, they smelled "smoke" in the house and found the pendant "smoking and hot." the customer reported they immediately unplugged the device and there was no one in the bed when they found the pendant smoking.The customer reported there was no medical intervention or serious injury related to the reported incident.Sample was requested for return 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 again.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.

Manufacturer Narrative

Investigation conclusion.

• Type of Device: PENDANT FOR MDR107002E
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16870489
• MDR Text Key: 314581122
• Report Number: 1417592-2023-00201
• 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: 07/06/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: MDR510094
• Device Lot Number: 45222050005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 07/06/2023
• 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