MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number M04S-C

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

Patient Problem Burn(s) (1757)

Event Date 07/17/2017

Event Type  Injury  

Event Description

Tonight, i put my daughter to sleep with a new bedwetting alarm i purchased on (b)(6).The alarm is the malem ultimate alarm, camouflage.It was placed as per the directions and she went to bed around 9pm.An hour ago, at 1:45am, i heard her shouting and screaming.My husband and i found that the alarm had burnt her neck and there was dark gray matter all round her neck and near her lips.Somehow the alarm has caused the batteries to leak and in the process also gotten so hot that it burnt my daughter in the neck.We have administered first aid and will be seeking medical attention.At this time, she has serious burn marks on and around her neck and chin.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6724540
• MDR Text Key: 80508870
• Report Number: MW5071073
• 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: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S-C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR