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

Model Number ULTIMATE PRO ALARM

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Date 12/17/2019

Event Type  Injury  

Event Description

Son was asleep with the alarm and complained that he wet the bed.The purpose of the alarm is to wake him up when he wets so he can stop bedwetting.However this alarm, in addition to making the noise also gave him a shock on his genitals.This completely unacceptable and scary for us.We can¿t use this product out of fear for safety.The batteries were dead from the shock.I tested it with my hands and i got shock as well when i touched the sensor with my wet hands.This alarm was purchased brand new and is unsafe.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 9516486
• MDR Text Key: 172901537
• Report Number: MW5091872
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO ALARM
• Device Catalogue Number: 8 TONE WITH VIBRATION
• Device Lot Number: BLUE COLOR
• 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; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 21