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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Defective Device (2588)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 05/26/2020

Event Type  Injury  

Event Description

Patient is a (b)(6) year old male child who wets the bed.Parents purchased bedwetting alarm from (b)(6) website.The alarm had malfunction causing injuries and burns to child.Child was admitted to er for burns (minor but spread on neck).The alarm failed due to defect in short circuit electrical part.It is believed as the battery holder bent from heat and batteries leaked on child's clothing and all over the alarm.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10128277
• MDR Text Key: 194526778
• Report Number: MW5094871
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• 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: 7 YR
• Patient Weight: 27