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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/02/2019

Event Type  Injury  

Event Description

After use for a week my daughter had burn marks on her skin she has stopped use of the product and her symptoms are better.The burns were caused by the alarm on her.It is hot and dangerous.I returned it back to (b)(6).Fda safety report id # (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8866308
• MDR Text Key: 153641979
• Report Number: MW5088834
• 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: 08/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR