MAUDE Adverse Event Report: MALEM ALARM COMPANY MALEM BEDWETTING ALARM

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Device Unsafe to Use in Environment (2918)

Patient Problem Burn(s) (1757)

Event Date 05/23/2017

Event Type  Injury  

Event Description

My daughter suffers from bedwetting and we were using another brand of alarms till we lost it.As a replacement, we purchased a malem bedwetting alarm with high expectations for my (b)(6) daughter.The product was purchased on (b)(6).There were many reviews on the product which spoke about the product overheating, but i overlooked it, i was wrong.The second night of use, the alarm literally exploded when it was in use.My daughter was wearing the alarm unit at her pajama top and the little battery door that houses the batteries melted and the batteries leaked out of the alarm.My poor daughter's chest burnt and she has burn marks now.She reacted by screaming out and crying out loudly at night.I was fortunately sleeping besides her when this happened.If i had not been there, it would have caused permanent harm.We had to rush her to the emergency room where she was treated through the night for burns.It appears that (b)(6) has removed this product and stopped selling it for safety reasons.We should not be risking children's lives with dangerous products.Malem alarms are just too dangerous to be sold where parents can access them and children can use them.There should be a product safety team that should look into this item promptly.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM ALARM COMPANY
• MDR Report Key: 6597851
• MDR Text Key: 76272054
• Report Number: MW5070063
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR
• Patient Weight: 25