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

Model Number M042

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437); Defective Device (2588)

Patient Problem Rash (2033)

Event Date 11/20/2019

Event Type  Injury  

Event Description

Alarm is defective.It overheated and caused injuries to my son.We had to stop using the alarm and take him to er for treatment.They said that the alarm leaked battery acid on him which caused skin rash, mental trauma and worry.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9402463
• MDR Text Key: 168874048
• Report Number: MW5091386
• 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: 11/28/2019

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: M042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR