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

Model Number ULTIMATE M042

Device Problems Overheating of Device (1437); Unstable (1667); Temperature Problem (3022)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 06/18/2019

Event Type  Injury  

Event Description

Alarm is unstable.Its getting hot with batteries and sensor plugged in.Heat is enough to cause injuries and skin burn.Have tried using the alarm with different brands of batteries but that does not help.The problem is either in the alarm itself or in the cable that detects urine.In any event, the alarm is too hot and unsafe to use.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: 8755342
• MDR Text Key: 150025869
• Report Number: MW5087766
• 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
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE M042
• 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): Required Intervention