MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL

Model Number M04S3EC

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

Bed wetting alarm was purchased new from (b)(6).The bed wetting alarm came with batteries and when put inside the device, it starts clicking and getting warm.About 30-45 mins later, the device gets so hot that it is hard to even hold it in the hand let alone place it on a child's body.The product is either defective or malfunctioning.Tried replacing batteries, but the same thing happened.Not used, returned back to seller.

• Brand Name: MALEM MEDICAL
• Type of Device: MALEM MEDICAL
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7305644
• MDR Text Key: 101475181
• Report Number: MW5075586
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S3EC
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR