MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M04S

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

Patient Problem Burn, Thermal (2530)

Event Date 03/01/2018

Event Type  Injury  

Event Description

I am a nurse and i often recommend the use of a bedwetting alarm (enuresis alarm) to patients.It was normal to get one for my daughter to help her stop bed wetting.However this has been a dangerous experience for us.The alarm does not function as advertised and instead can cause more home and damage.From our experience, the alarm gets warm when batteries are inserted and keeps getting hotter and hotter over time.Even though we replaced batteries many times, this did not change what happens.I put my daughter to bed thinking that this was just operational, but when my daughter got burnt from the alarm, i know that there was an issue with the alarm reliability.The batteries spilled out of the alarm onto her body and she was covered in battery acid.The alarm was so hot that i could have easily burnt my finger from touching it.Needless to say, it also burnt my daughter's neck a little bit.We took appropriate care and rinsed the burnt area, but it worries me that this could have been even more deadly if it had continued unchecked.The product has been returned to the manufacturer.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; gb ; UK
• MDR Report Key: 7326958
• MDR Text Key: 102088017
• Report Number: MW5075757
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 15