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

Model Number MS04C

Device Problems Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Date 07/03/2017

Event Type  Injury  

Event Description

Bought a malem alarm for my son.The doctor had prescribed the alarm and said it would stop his nighttime bedwetting.Purchased the alarm on (b)(4) and it arrived on monday (b)(6).The night we put in batteries and used it, the alarm made a loud hissing sound like something was stuck and the back of the alarm started getting very hot.Unfortunately, my son had just clipped it on to his t-shirt.By the time we removed the alarm, we noticed that there were red marks on his neck.He was burnt from the alarm.A few minutes later, the batteries in the alarm started leaking.It has been returned to (b)(4) this morning.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6692483
• MDR Text Key: 79365581
• Report Number: MW5070817
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: MS04C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR