MAUDE Adverse Event Report: MALEM UNITED KINGDOM / MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITINED RESPONSE ENURESIS

Model Number M04SC

Device Problems Burst Container or Vessel (1074); Electrical Shorting (2926)

Patient Problem No Information (3190)

Event Date 09/04/2018

Event Type  Injury  

Event Description

On a vacation we were using an enuresis alarm in the hospital.The alarm shorted the batteries and exploded.The back side of the alarm is significantly deformed from the heat that was generated by the batteries shorting out.The enuresis alarm is not safe for my son.If i had not responded quickly, it is highly possible that my son would have been burnt rather seriously.The alarm was clamped to his neck region and he was asleep when this happened.I have reached out to the seller and mfr, but have not heard back.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITINED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM UNITED KINGDOM / MALEM MEDICAL LTD; 17737 new hamshire ave; ste 100; ashton MD 20861
• MDR Report Key: 7868501
• MDR Text Key: 120186287
• Report Number: MW5079704
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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: 9 YR
• Patient Weight: 32