MAUDE Adverse Event Report: MALEM BEDWETTING ALARM TO CURE BEDWETTING; ALARM, ENURESIS

Model Number NONE

Device Problem Burst Container or Vessel (1074)

Patient Problem Burn, Thermal (2530)

Event Date 09/02/2016

Event Type  Injury  

Event Description

I live in (b)(6) and i purchased the malem bedwetting alarm from the us for my (b)(6) as a potty training device and an alarm for him to cure his nighttime bedwetting.On the third night while using the alarm it abruptly exploded and burnt my son's neck.This malem bedwetting alarm is utter nonsense and should be removed from sale in (b)(6) and us.Does this product have any safety guidelines? my son was hurt and i expect us fda to take my complaint seriously.I don't know.You need to see if this product has any lab tests or reports since the time its being sold in the us and (b)(6).

• Brand Name: MALEM BEDWETTING ALARM TO CURE BEDWETTING
• Type of Device: ALARM, ENURESIS
• MDR Report Key: 5942494
• MDR Text Key: 54532911
• Report Number: MW5064658
• Device Sequence Number: 1
• Product Code: KPN
• 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: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 0
• Treatment: OTC MEDS: NONE. ; RX MEDS: NONE.
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR
• Patient Weight: 15