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

Model Number M043 - PURPLE

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2019

Event Type  Injury  

Event Description

On the night of (b)(6), a patient was treated for skin burns from an enuresis alarm.The patient is a young child who was prescribed an alarm for treatment of primary nocturnal enuresis.The child has been dealing with nocturnal enuresis for several years and this was the first alarm treatment and first device used.Parents have said that the alarm and sensor were connected together as directions indicated.At first, everything appeared to be normal.But they heard the alarm going off at night and their child crying.On checking, they observed that the device had leaked and the child was burnt from excess heat generated by the alarm.Parents brought child to the hospital for treatment.We have checked and determined that the incident is related to the alarm malfunction.There have been prior reports of this alarm brand injuring children as well.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8362693
• MDR Text Key: 137163106
• Report Number: MW5084226
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M043 - PURPLE
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• 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: 5 YR