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

Model Number ULTIMATE ALARM

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981); Explosion (4006)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 09/01/2019

Event Type  Injury  

Event Description

Daughter was prescribed a bedwetting alarm by dr (b)(6).He recommended that we go online and purchased one for our (b)(6) year old daughter.We got malem ultimate after all the ads we saw online.It is simple to use and operate but when my daughter went to sleep with the alarm, the batteries inside exploded and hurt her.She woke up at night.I think she was asleep for only 30 mins and was scared and crying.Her alarm was sticky.Both batteries leaked from the alarm and the alarm itself was hot and the blue color plastic cover had twisted.There was so much heat from this alarm that the shape changed.So dangerous, it also hurt her where it was connected.I met with dr (b)(6) in the morning and his office told me to report to fda.How can this small alarm be so dangerous that it can even burn skin? my daughter is scared and worried.We can't use this or another alarm like this on her from fear of hurting her.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8970295
• MDR Text Key: 157070470
• Report Number: MW5089601
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/03/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: BLUE
• Device Lot Number: M042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR