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

Model Number NOT KNOWN - RED COLOR

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Emotional Changes (1831); Caustic/Chemical Burns (2549)

Event Date 12/09/2017

Event Type  Injury  

Event Description

We used a bedwetting alarm last night on my son.Within a few minutes of use, the alarm literally exploded at night and injured my son.The back housing of the alarm got very hot and that probably caused the alarm to explode.Batteries exploded inside the alarm and leaked out.The battery leak was so hot that it burnt my son's skin.I am shocked.I had to immediately rinsed his neck with fresh water and rushed him to the hospital where he was treated for chemical burns from the batteries.He has suffered psychological stress and emotional harm from the battery explosion.

• Brand Name: MALEM, ALARM CONDITIONED RESPONSE ENURESIS
• Type of Device: MALEM, ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL COMPANY
• MDR Report Key: 7112036
• MDR Text Key: 94808014
• Report Number: MW5073924
• 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: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NOT KNOWN - RED COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 19