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

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/07/2019

Event Type  Injury  

Event Description

Over the weekend, we used the malem bedwetting alarm which we purchased from the bedwetting store.This garbage product over heated and burnt my child.What¿s going on with this alarm? the fda needs to step in and look into this issue.Bedwettingstore.Com.Fda safety report id # (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESUS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9465905
• MDR Text Key: 170950239
• Report Number: MW5091640
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 12/10/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 MO