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

Model Number ULTIMATE SELECTABLE BEDWETTING

Device Problems Electrical /Electronic Property Problem (1198); Leak/Splash (1354); Mechanical Problem (1384); Overheating of Device (1437)

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

Event Date 02/01/2019

Event Type  Injury  

Event Description

(b)(6) year old boy was prescribed an enuresis alarm for his bed-wetting problem.The pediatrician recommended a malem brand alarm.Parents used the alarm as directed by the instructions, but the alarm has an electrical/mechanical problem which caused it to malfunction and overheat.The alarm has burnt the child on his body where the alarm was in contact and batteries leaked on boy¿s body and clothing.Our office has treated the child and returned the alarm to the parents.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD; nottingham gb
• MDR Report Key: 8359210
• MDR Text Key: 137130529
• Report Number: MW5084192
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: SG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTIMATE SELECTABLE BEDWETTING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR