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

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Sleep Dysfunction (2517); Sleep Dysfunction (2517); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Malem alarms are the most dangerous, unsafe and unreliable children's product that i have bought till date.On what grounds can anyone sell a product that can burn your child and put them in a horrific situation that you feel like throwing all malem alarms in the deep sea.My son suffered high degree of burn marks which has caused him trauma and now he is getting sleepless nights.All malem alarms should be called back for a safety check in the interest of children who have purchased the alarm or intent to purchase it.Fda should look into this matter as it is serious and urgent.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6743437
• MDR Text Key: 241266672
• Report Number: MW5071227
• Device Sequence Number: 0
• Product Code: KPN
• 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: 07/24/2017
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR