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

Model Number M043

Device Problem Device Alarm System (1012)

Patient Problem Burn, Thermal (2530)

Event Date 06/06/2019

Event Type  Injury  

Event Description

My son was asleep with malem bedwetting alarm for treatment of his bedwetting when the alarm malfunctioned and burnt him on his neck.We are very scared to use another system.The burns he suffered are traumatic and he's in depression.We treated him at home and will discuss with his doctor also.Fda safety report id # (b)(4).

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8692564
• MDR Text Key: 147994423
• Report Number: MW5087293
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Device Lot Number: ULTIMATE
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR