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

Model Number M042

Device Problems Leak/Splash (1354); Device Emits Odor (1425)

Patient Problems Pain (1994); Rash (2033)

Event Date 11/10/2019

Event Type  Injury  

Event Description

Alarm burst at night and leaked battery acid on son's skin near neck.He is screaming in pain.This is a bedwetting alarm and not intended to harm a child.We are scared to use it.Heat has deformed alarm plastic as well and smells of burning plastic.Rash.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: 9316214
• MDR Text Key: 166396180
• Report Number: MW5091023
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM
• 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): Other
• Patient Age: 4 YR