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

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 08/06/2019

Event Type  Injury  

Event Description

I just inserted batteries as per the directions into the alarm and its hot.Also, the alarm is smelling bad like its burning.Being hot and burning smell makes me scared to use it for my son.I changed batteries 3 times and its constantly doing the same thing over and over.Too scared to use on son.He may faint from the bad smell near his nose.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: 8894530
• MDR Text Key: 154439632
• Report Number: MW5089044
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• 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