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

Model Number M04

Device Problems Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 03/11/2018

Event Type  Injury  

Event Description

Over the weekend, my son's bedwetting alarm which he used for the last 3 days suddenly malfunctioned.It was being used at night when he was sleeping.The alarm batteries leaked out at night and the battery acid has scarred and burnt my son on his neck.The alarm was very hot when we removed it.If we had not removed it on time, i worry that it would have caused serious damage to my son's neck.Unfortunately we did not remove the alarm on time and the neck has been burnt by the alarm.He was taken to the hospital for emergency treatment.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM CORPORATION
• MDR Report Key: 7337389
• MDR Text Key: 102457463
• Report Number: MW5075840
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• 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): Other
• Patient Age: 8 YR