MAUDE Adverse Event Report: MALEM MEDICAL LIMITED MALEM; ALARM CONDITIONED RESPONSE

Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Inoperable (1663)

Patient Problems Reaction (2414); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 06/23/2018

Event Type  Injury  

Event Description

Parents came in to the er with child who had suffered burns from the normal use of an enuresis alarm.It appears that the alarm somehow got very hot to a point where the plastic housing began to bend inwards from heat and caused the 2 housed batteries to leak onto the child's neckline.Child has suffered allergic reaction to the alarm and skin rash as a severe side effect of the same.Child was administered with first aid and discharged as per routine procedure.The alarm was returned to the parents.Device appears to have malfunctioned and overheated to hurt child in the neck.Missing on product.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LIMITED; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7650120
• MDR Text Key: 112851784
• Report Number: MW5078139
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 6 YR
• Patient Weight: 22