MAUDE Adverse Event Report: MALEM MEDICAL LTD ALARM FOR BEDWETTING; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04S

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

Patient Problem Burn, Thermal (2530)

Event Date 09/30/2018

Event Type  Injury  

Event Description

Yesterday my (b)(6) y/o son was sleeping in his room with his bedwetting alarm and he was burnt from the overheating of the alarm.I took my son to the dr's office and they told me to complain on this website.This is a malem alarm and i purchased it from (b)(6) online.It was new and was not used.The alarm was only worn by my son for no more than 1 hour and it burnt his neck.The alarm is now not operating.It has failed from the heat it generated.The batteries leaked inside the alarm and it has become useless.My son has blister like patches on his neck and he is seeking appropriate medical treatment.

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; 17737 new shamshire ave; ste 100; ashton MD 20861
• MDR Report Key: 7929744
• MDR Text Key: 122640886
• Report Number: MW5080288
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 27