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

Model Number M05

Device Problem Leak/Splash (1354)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2018

Event Type  Injury  

Event Description

My son burnt in his neck when he was sleeping with a malem alarm bedwetting alarm.He is 5 years old and was sleeping with the alarm when he started crying in pain and we noticed that his alarm was leaking batteries and burnt his neck.There was also a small hole in his t-shirt where the alarm touched the sink.This is so scary and we don't want to continue to use this product anymore.It is not safe for son.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8138862
• MDR Text Key: 129770564
• Report Number: MW5081892
• 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: 12/03/2018

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
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 19