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

Model Number M05

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problems Discomfort (2330); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 12/06/2018

Event Type  Injury  

Event Description

My (b)(6) year old son was burnt on his neck by the malem bedwetting alarm.It has caused extreme pain and mental discomfort.We used a brand new alarm which was malfunctioned on the first night.Excess heat caused the alarm to bend and batteries to leak.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 8150899
• MDR Text Key: 130313944
• Report Number: MW5081990
• 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: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR