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

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549)

Event Date 11/05/2018

Event Type  Injury  

Event Description

Our clinic has received a complaint that an enuresis alarm which was purchased by a family has malfunctioned and burnt the child at night when he was asleep.We have treated the child and the attending nurse has been following up with the family.There was no fault of the child or family.It is clear from the device received, that the device is defective.The batteries have leaked from heat generated from the alarm and burnt the child's neck.The child has red blisters and skin rash on his neck as a result of the burns.We believe the child will be back to health in 2-3 weeks.Enuresis alarm.

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD ; gb
• MDR Report Key: 8070959
• MDR Text Key: 127400528
• Report Number: MW5081256
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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