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

Model Number M04B

Device Problems Leak/Splash (1354); Electrical Shorting (2926)

Patient Problems Bruise/Contusion (1754); Scarring (2061); Burn, Thermal (2530)

Event Date 11/05/2018

Event Type  Injury  

Event Description

Our clinic treated a (b)(6) boy who has been burnt from an enuresis alarm.The child is stable but has big bruises on his neck where the alarm was touching his skin.This is the result of an electrical malfunction in the alarm.The device short circuited and caused batteries to leak.The batteries spilled onto the child's body.A combination of hot plastic and battery scarred the child's skin while he was asleep.We have recommended that the parents discontinue using the alarm.We have returned the alarm back to the parents.The alarm housing has bent inwards from excess heat.

• Brand Name: MALEM
• Type of Device: "ALARM, CONDITIONED RESPONSE ENURESIS"
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham NG147 EJ; UK NG147EJ
• MDR Report Key: 8074490
• MDR Text Key: 127532132
• Report Number: MW5081297
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: M04B
• 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): Hospitalization
• Patient Age: 4 YR
• Patient Weight: 17