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

Model Number BLUE SELECTABLE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The sensor was placed on underwear as directed to detect wetness.My son probably moved in bed and slept on top of the sensor.As he did, the sensor broke and there were two very sharp pronged metal sheets in the sensor.These were sharp and pierced his skin while he was asleep.He said it felt like a bee sting and woke up.The sensor was stuck in his skin and i had to carefully remove it.During the process, the metal was left in his skin and had to be removed with tweezers.The cut was similar to one with a sharp piece of glass.The alarm can not be used anyone and sensor is damaged from sleep.Fda safety report id # (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9504598
• MDR Text Key: 172621104
• Report Number: MW5091797
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BLUE SELECTABLE
• 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