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

Model Number M04S

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Son was hurt, (burnt), at night when he was sleeping with the bedwetting alarm.We entered his room and smelt something burning and realized that it was the bedwetting alarm that had burnt.It also hurt his skin.We took him to the doctor for treatment.The doctor told us to contact fda and report this incident.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED REPSONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8456046
• MDR Text Key: 140160069
• Report Number: MW5085179
• 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: 03/23/2019

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: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR