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

Model Number ULTIMATE

Device Problem Explosion (4006)

Patient Problems Pain (1994); Swelling (2091); Injury (2348); Burn, Thermal (2530)

Event Date 06/15/2020

Event Type  Injury  

Event Description

Burns; the bedwetting alarm has malfunctioned in the middle of the night, just 30 minutes into my sons sleep.The alarm exploded causing batteries to leak and cause neck injuries.My son was sleeping on his stomach when the explosion happened.We had to take him to the er in the middle of the night.It is unfortunate.He was injured and has blisters (painful) on his neck.We are frightened to use the bedwetting alarm and his wetting has gotten worse.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10189373
• MDR Text Key: 196446423
• Report Number: MW5095181
• 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: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 8 YR