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

Model Number BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Defect in the bedwetting alarm caused to overheat and injure my son in his sleep.The alarm was connected on him as the user manual and instructions.Within 30 mins, he was injured and the alarm overheated leaving a red scar on his neck.Fortunately i was able to give him treatment for small burns on time.If not, it would have easily resulted in blisters and painful tears on the skin.Alarm was returned to mfr as is no longer safe to operate.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9523944
• MDR Text Key: 173042244
• Report Number: MW5091892
• 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: 12/24/2019

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: BEDWETTING ALARM
• Device Catalogue Number: ULTIMATE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• 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: 5 YR