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

Model Number ULTIMATE

Device Problem Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530)

Event Date 03/09/2019

Event Type  No Answer Provided  

Event Description

On saturday night, our office received a call that a child was injured in sleep using a bedwetting alarm.We told the parents to come over so we can analyze the cause of the problem.We treated the child (a (b)(6) girl) with minor skin bruises and burns on her neck.The cause of burns can be attributed to the bedwetting alarm getting hot and burning the child's neck.Parents have taken the alarm and we are reporting it on their behalf.This is an uncommon problem and the issue is the result of alarm failure.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8424743
• MDR Text Key: 139164495
• Report Number: MW5084924
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Device Catalogue Number: 04 MODEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR