MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; BEDWETTING ALARM

Model Number M04S

Device Problems Leak/Splash (1354); Melted (1385); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 10/03/2018

Event Type  Injury  

Event Description

On (b)(6), a family brought in their child at 10:30 pm to our clinic.The child had been injured from the use of a malem bedwetting alarm.Parents had used a new alarm which was purchased online from (b)(6) website.The alarm was shipped and arrived to parents a day before the incident.The parents said that they set up the malem alarm as was instructed in the user manual and the boy went to sleep.The boy complained of an extremely hot object touching his neck and then parents realized and removed the alarm.By then, there was a skin burn on the boy's neck.In our clinic, we treated the boy and let him go.He was diagnosed with skin burns.The alarm has deformed from heat that was produced by the malem alarm and there were indications of battery leak and discharge on the alarm.The alarm bottom which is made of plastic has partially melted from heat.The battery leak also was on the boy's neck and he has suffered from allergic reaction.The clinic has returned the alarm to the parents.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham ; UK
• MDR Report Key: 7956070
• MDR Text Key: 123506295
• Report Number: MW5080453
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: GT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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): Hospitalization
• Patient Age: 6 YR
• Patient Weight: 21