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

Model Number M04S

Device Problems Material Disintegration (1177); Melted (1385); Temperature Problem (3022); Noise, Audible (3273)

Patient Problems Swelling (2091); Burn, Thermal (2530)

Event Date 07/17/2017

Event Type  Injury  

Event Description

My son was using the malem bedwetting alarm on (b)(6) night.Within 3-4 hours of use, the alarm suddenly started making a clicking sound.I removed it from my son and took out batteries.Then reinserted it again.I realized that the alarm was warm, not hot, but warm.I thought it was normal from use.Reinserted batteries and the alarm continued to make a clicking sound.I removed batteries and set it aside for the night.The next night, reinserted the batteries and the alarm did not make any sound.It appeared to be cool.However 4 hours later, i smelt something strange.I turned the lights on and saw that the batteries inside the alarm had leaked out on my sons neck.I was surprised he was still asleep.The alarm was making a clicking sound.I removed the alarm and the backside of the malem alarm was very hot.The blue battery door had shrunk out like it had changed shape from the heat.The alarm kept making clicking sounds and then stopped.In the process, the battery door was completely disintegrated.My son had battery gue stuff on his neck.I was not sure if it was toxic or not.I treated my son by using a cold wet cloth, but in the process, he now has 3 big blisters on his neck from the heat.He was taken to the pediatrician who told us to report the incident to the fda.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham NG14 7EJG; UK NG14 7EJGB
• MDR Report Key: 6739694
• MDR Text Key: 81037181
• Report Number: MW5071174
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Life Threatening
• Patient Age: 4 YR
• Patient Weight: 20