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

Model Number ULTIMATE M042

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Unfortunately the alarm didn't work.As soon as we placed the batteries in and got ready to test it, it became extremely hot and smelled like burned plastic.I immediately removed the batteries and replaced them with new ones; same thing.The device is super hot and smelling like it's on fire.It's kind of scary thinking that it could happen in the middle of the night and burn the child.Discussed with dr and they suggested i reach out to fda to complain.Also, said i should leave alarm with them and they would contact the mfr.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8793432
• MDR Text Key: 151296386
• Report Number: MW5088129
• 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: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE M042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR