MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M04S

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Chemical Exposure (2570)

Event Date 12/08/2017

Event Type  Injury  

Event Description

A brand new make alarm which i purchased for my boy exploded at night while it was putting it on him.The alarm was purchased from the (b)(6) website.I put in batteries into the malem alarm and i was setting up the sensor on him.As i attached the same, a few mins later, i connected the alarm and sensor and proceeded to put on his t-shirt.As i was doing it, the malem alarm started to get hot and exploded as soon as it was attached.The batteries shorted out and leaked onto his clothing and ruined his t-shirt.I am fortunate to have caught it at the right time or the alarm would have seriously injured my son.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 7137441
• MDR Text Key: 95532534
• Report Number: MW5074133
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/17/2017

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: Health Professional
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 23