MAUDE Adverse Event Report: MALEM MEDICAL, LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M048TEC

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  Injury  

Event Description

Our second malem alarm has also malfunctioned.The first one started acting up when we placed batteries inside it.It would get hot.We thought this was an issue with the alarm and possibly damaged during shipment.We returned it back to (b)(6) and bought another one to replace it.The same thing happened again.This product gets hot when i insert batteries.The longer the batteries are left in the alarm, the more hot it gets.My son was to wear it all night long, but seems that this is not a safe product.Prior to this alarm, we were using a wetstop-3 alarm which was working fine till the cord kept breaking.This product has also been returned over the weekend.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 7471879
• MDR Text Key: 106896915
• Report Number: MW5076815
• Device Sequence Number: 2
• 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: 04/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M048TEC
• Device Catalogue Number: BLUE COLOR
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22