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

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 09/10/2017

Event Type  Injury  

Event Description

We bought the malem bedwetting alarm from (b)(6).During the first week, we noticed that the alarm used to get a little warm sometimes but we thought that was normal.However, when we were into the beginning of the second week my son faced burns from this alarm.I believe something in the internal circuitry must have gone terribly wrong and the alarm overheated.My son was fast asleep when this happened, as soon as he felt the heat, he took the sensor cable off followed by the alarm then threw it on the floor.He rushed to my room and i noticed that he had faced severe burns on his neck and chest.I applied an ice pack on his burns and in the meanwhile my husband was kicking the alarm on the floor as it was unusually hot and the batteries needed to be removed.The only way to remove the batteries was to wear an oven mitt and pick up the alarm then put in cold water after which it drenched and stopped working.We had to take 4 trips to the doctor every other day to change his bandage.This is not right.I don't know what the fda has done to evaluate this product so far.But whatever be the case, this company should not be allowed to sell products to consumers.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): BEDWETTING STORE & MALEM MEDICAL
• MDR Report Key: 6857629
• MDR Text Key: 86009428
• Report Number: MW5072098
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 09/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention