MAUDE Adverse Event Report: MALEM MALEM; BEDWETTING ALARM

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Pain (1994); Caustic/Chemical Burns (2549); Superficial (First Degree) Burn (2685)

Event Date 09/26/2017

Event Type  Injury  

Event Description

Four days ago a parent brought in her (b)(6) daughter who was badly burnt and bruised by the use of an enuresis alarm.The child had used the enuresis alarm at night and the alarm had exploded causing battery leaks.The mother also told us that the child was screaming in pain.The alarm is in our possession and we can see that the batteries have leaked as a result of overheating and poor design.The battery acid that had leaked on the child's neck and chest could have been fatal for this child due to the nature of the battery leak and temperature.The child was administered with appropriate treatment and discharged.Child has suffered first degree burns and bruises.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6910676
• MDR Text Key: 88140306
• Report Number: MW5072559
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 4 YR