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

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Type  Injury  

Event Description

The malem alarm which was purchased from the (b)(6) simply overheated and burnt my son on his neck.There is a problem with the malem alarm.The fda needs to inspect this product.My son is now suffering with pain.The rep at the (b)(6) initially disconnected my phone and now does not pick up my phone altogether.With so many complaints and so many children being burnt, something should be done soon.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8960547
• MDR Text Key: 156654159
• Report Number: MW5089532
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• 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