MAUDE Adverse Event Report: MALEM MEDICAL MALEM ALARM; ENURESIS MONITOR

Device Problems Thermal Decomposition of Device (1071); Burst Container or Vessel (1074); Overheating of Device (1437); Device Displays Incorrect Message (2591); Chemical Spillage (2894)

Patient Problems Injury (2348); Caustic/Chemical Burns (2549)

Event Date 05/22/2017

Event Type  Injury  

Event Description

I am very angry and upset with my purchase of the malem bedwetting alarm off of (b)(6).I ordered the item in (b)(6) and started using it shortly thereafter.My (b)(6) son suffers from bedwetting and i purchased this alarm for him.He has used it only 3 times and every night, the alarm got extremely hot.The third night, my son cried out in pain in the middle of the night and i went running to his room.His t-shirt had burnt through and there was gray matter around his chest.I removed the alarm and in the process i burnt my fingers.Upon inspection, i found that the malem alarm had overheated and the batteries exploded inside the alarm unit.The batteries leaked out and the dangerous chemical residue spilled on my son's neck and burnt a hole in his t-shirt.Now my son has scars on his neck for no fault of his.We have to take him to the doctor's office and they are treating the burns.I also contacted (b)(6) and they have removed malem alarms form their website for safety reasons.Several parents had written reviews where the alarm had overheated and burnt children's neck in the middle of the night.I am so disappointed that this happened to my son.It could have lead to something even more dangerous if i had not intervened.Why should we suffer for a poor quality and unsafe product.This is a very dangerous and unsafe children's product.It should not be sold to the public in my opinion.

• Brand Name: MALEM ALARM
• Type of Device: ENURESIS MONITOR
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6614117
• MDR Text Key: 76740462
• Report Number: MW5070174
• Device Sequence Number: 1
• Product Code: KPN
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR