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

Model Number MALEM ULTIMATE BEDWETTING ALARM

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 01/21/2019

Event Type  Injury  

Event Description

Our client rents out enuresis alarms to parents for the treatment of primary nocturnal enuresis.These alarms are purchased from the manufacturer and rented to patients.The duration is usually 3-6 months.We purchased our first malem bedwetting alarm from the manufacturer in (b)(4) and rented to a patient.Device operation involves inserting batteries and sensor, in that order.Patient complained that within 45 minutes of inserting sensor, the alarm was extremely hot , making it unusable.The patient changed batteries and replaced sensor, however that did not resolve the problem.Each time , on changing the batteries, the device would appear to cool down, but when sensor was inserted, would start reheating itself.The patient suffered burns around neck where the device was connected.Device has problem as use is not complicated.Device is getting too hot for normal use.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8277843
• MDR Text Key: 134438396
• Report Number: MW5083380
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2019

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: Lay User/Patient
• Device Model Number: MALEM ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: M04SB - ROYAL BLUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 25