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

Model Number MO4SECB

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Electrical Shorting (2926)

Patient Problem Irritation (1941)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

Batteries leaked from within a brand new bedwetting alarm and spread onto child's clothing at night.The cause of the battery leak was a defect in the bedwetting alarm.It somehow shorted out during normal operation and caused batteries to explode.The battery leak caused skin irritation but the heat generated from the battery short was enough to nearly melt the plastic casing of the bedwetting alarm.If not intervened on time, this may have been extremely dangerous.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7316280
• MDR Text Key: 101711064
• Report Number: MW5075653
• 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: 03/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO4SECB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR