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

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Defective Device (2588); Battery Problem (2885); Material Twisted/Bent (2981)

Patient Problem Burn, Thermal (2530)

Event Date 01/08/2019

Event Type  Injury  

Event Description

The enuresis alarm which the doctor gave to patient has hurt patient.Alarm has defective issue.Alarm got too hot when patient used included batteries.Burn marks are small but visible, close to neck region of the boy.Parents only used alarm once during the first night that incident occurred.Parents took immediate action and brought patient to clinic at night for recommended treatment.Alarm plastic has bent from heat.Batteries short out and injured patient at night.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8261181
• MDR Text Key: 133847634
• Report Number: MW5083245
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2019
• 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): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 29