MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ENURESIS ALARM

Device Problems Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problems Bruise/Contusion (1754); Irritation (1941); Pain (1994); Burn, Thermal (2530)

Event Date 03/28/2018

Event Type  Injury  

Event Description

Parents brought in a child who was bruised by a bedwetting alarm.On close observation, there was nothing wrong with the way the parents had operated the device, but the bedwetting alarm had malfunctioned under normal use.The child was bruised from abnormal heat generated by the alarm which had burnt the child's neck and chin.Additionally, the batteries in the alarm portion had short circuited and caused the batteries to leak on to the child's skin.The burning and battery leak is a dangerous combination which caused severe pain and irritation to the child.He was treated in the hospital and discharged.Follow up treatment is underway.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL UK; gb
• MDR Report Key: 7391583
• MDR Text Key: 104272725
• Report Number: MW5076258
• 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: Physician
• Type of Report: Initial
• Report Date: 03/29/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR