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

Device Problem Leak/Splash (1354)

Patient Problems Injury (2348); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 10/17/2019

Event Type  Injury  

Event Description

Our clinic treated a young (b)(6) y/o girl who had been injured by a bedwetting alarm.Parents said that the alarm burnt the child.We noticed that the alarm has batteries leaking and there was battery spill all over the alarm body.The child had blisters on her chest area where the hot alarm was touching her skin.Alarm has been returned back to parents who would return it to the mfr (malem).Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL ; UK
• MDR Report Key: 9255381
• MDR Text Key: 164601170
• Report Number: MW5090767
• 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: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 24