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

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Device (2588)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549)

Event Date 09/18/2018

Event Type  Injury  

Event Description

The enuresis alarm burnt my son.It got very hot and my son got burnt in sleep.Alarm is defective and dr told me to file complaint on-line.Battery leak from alarm on my son's neck and caused skin rash also.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; 17737 new hampshire ave; ste 100; ashton MD 20861
• MDR Report Key: 7929786
• MDR Text Key: 122649456
• Report Number: MW5080291
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 09/29/2018

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
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 30