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

Model Number M04

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Burn, Thermal (2530)

Event Date 09/04/2018

Event Type  Injury  

Event Description

A new malem bedwetting alarm burnt my daughter when she was sleeping.She had to be taken to the hosp and was in extreme pain.She was in the hosp for a night as they treated the big burns on her body.The burns were a result of the bedwetting alarm malfunctioning and getting hot to where it burnt her.

• 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: 7868489
• MDR Text Key: 120139914
• Report Number: MW5079703
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 3 YR
• Patient Weight: 15