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

Model Number PRO ALARM FOR BEDWETTING

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 08/22/2019

Event Type  Injury  

Event Description

A patient was brought in complaints of skin irritation from burns which resulted in the use of an enuresis alarm.The malem enuresis alarm was used by the patient and the device has developed an internal fault which caused it to become hot and burn the patient's skin while he was sleeping.The patient was unable to reach and remove the enuresis alarm on time and it caused the alarm to burn him.The runs were not severe, but the patient was also exposed to hot battery leak acid which made condition worse.Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8944542
• MDR Text Key: 156087210
• Report Number: MW5089416
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PRO ALARM FOR BEDWETTING
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization
• Patient Age: 5 YR