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

Model Number M048TEC

Device Problems Bent (1059); Leak/Splash (1354)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 05/16/2018

Event Type  Injury  

Event Description

Last night, my son's enuresis alarm malfunctioned while he was asleep.The alarm was used for less than a day, in fact used for about 2 hrs.My boy cried out in pain and when i went to his room.I noticed that his hands and neck were covered with battery leak which resulted from the bedwetting alarm shorting out the batteries.In addition to batteries leaking, the alarm also generated a large amount of heat which caused the back part of the plastic to bend and deform.I took my boy to urgent care for treatment.The alarm has left a bunch of small red scars on his neck where the alarm was touching skin and where the batteries had leaked.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 7533463
• MDR Text Key: 108945687
• Report Number: MW5077340
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• 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; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 23