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

Model Number M04

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/22/2018

Event Type  Injury  

Event Description

Mother brought in (b)(6) daughter who was badly burnt from using a bedwetting alarm.The child was prescribed a bedwetting alarm for the treatment of primary nocturnal enuresis.Parent said that the alarm was purchased from an online website - www.Bedwettingstore.Com.The parent said that the alarm was used for no more than 45 mins for one night and the alarm malfunctioned and overheated.The two aaa batteries that are housed inside the bedwetting alarm got extremely hot and exploded within the device.The explosion caused the batteries to leak on to child's body and burnt child in the neck area.The parent brought in the child for treatment which was appropriately done by the attending physician.The bedwetting alarm plastic housing has melted from excess heat and burnt a hole through the child's clothing.The alarm was given to the physician and this report is being made on that behalf.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM CONDITIONING RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham NG147 EJ; UK NG147EJ
• MDR Report Key: 7214780
• MDR Text Key: 98187138
• Report Number: MW5074740
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 20