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

Model Number M042

Device Problem Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 05/06/2019

Event Type  Injury  

Event Description

Son injured in sleep when using bedwetting alarm, new alarm burnt son in neck area in sleep.Not good, dangerous.Contacted company but no response to problem.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8608028
• MDR Text Key: 145138632
• Report Number: MW5086596
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR