MAUDE Adverse Event Report: MALEM CORPORATION MALEM BEDWETTING ALARM; ENURESIS ALARM

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Electrical Shorting (2926)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 12/24/2017

Event Type  Injury  

Event Description

The malem alarm has exploded the first night of use.The batteries shorted out and leaked out and burnt my son's neck.The alarm is new and arrived only 4 days ago.The hot battery acid spilled out of the alarm part onto my boy's neck and burnt him.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM CORPORATION
• MDR Report Key: 7150583
• MDR Text Key: 96013273
• Report Number: MW5074260
• 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: 12/25/2017

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR