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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/22/2019

Event Type  Injury  

Event Description

Son refuses to wear the bedwetting alarm as he complains that it is stinging him.He connects the alarm and within a few minutes complains that the alarm is too hot and hurts his skin.I tested it and this is the case.Its ok when the sensor is not plugged in.But when the sensor is plugged in, its temperature increases and then it gets hot and unusable.I don't know how hot it will get but its scary.This is very hot and unusable at night safely.Fda safely reports id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8658919
• MDR Text Key: 146853214
• Report Number: MW5087057
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE
• 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: 5 YR