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

Model Number SELECTABLE ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Device (2588)

Patient Problem Burn, Thermal (2530)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Defective alarm has caused my son to suffer.The alarm overheated when he was sleeping and burnt him in his neck.This is not rash, but clearly skin burnt from the bedwetting alarm, it was used as described and the alarm has certainly a defect that caused it to behave like this.When we removed it from son, its heat could have burnt my hands.Used a towel to place it on the table top.Within a few mins, the alarm stopped heating up.On inspection, i noticed that the batteries had discharged and the heat bent the alarm plastic.Not what was expected for a children's product.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8273944
• MDR Text Key: 134094543
• Report Number: MW5083308
• 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: 01/18/2019

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
• Device Model Number: SELECTABLE ALARM
• Device Catalogue Number: 04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 16