MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM; ENURESIS ALARM

Model Number M04S

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 12/04/2017

Event Type  Injury  

Event Description

Our bedwetting alarm exploded last night when it was being used by my son.The alarm overheated and the batteries exploded inside the alarm unit.The hot battery liquid leaked on to my son's neck and chest and burnt him.My son was taken to the hospital for treatment in the middle of the night.They treated him with a wash and he has severe swelling on his body as an allergic reaction to the battery liquid.The blisters have not gone even after 1 week.The alarm was brand new and received only 4 days before the incident.I purchased it from (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7116536
• MDR Text Key: 94940167
• Report Number: MW5073953
• 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: 12/12/2017

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: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 24