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

Model Number M04S

Device Problem Overheating of Device (1437)

Patient Problems Swelling (2091); Reaction (2414); Burn, Thermal (2530)

Event Date 10/19/2018

Event Type  Injury  

Event Description

Our pediatric clinic has received 3 cases of children getting burnt from using a malem enuresis alarm at night.(b)(6), incident date: (b)(6) 2018; (b)(6), incident date: (b)(6) 2018; (b)(6), incident date: (b)(6) 2018.All of the three children are male and were suffering from nocturnal enuresis.Our pediatrician clinic has purchased 10 enuresis alarm from the mfr/distributor and have given 4 to pts over the last month.These were resold; 3 of the 4 children who used the alarm have reported adverse effect from the alarm.In all 3 cases, the adverse action was a result of a device malfunction which caused the alarm to overheat, leak battery acid on children's skin and caused severe burns on the child.The 3 children were all treated for burns and allergic reaction to toxic battery acid.The alarms have been returned to the clinic and are in the possession of the clinic.The remaining 6 alarms which were distributed have been called back as well.All three of the alarms clearly show that the alarm has generated so much heat at the back that it was more than enough to deform the thin plastic case which supports the batteries.The alarms were all new.Two of the three children have blisters on the neck region of the body from burns caused by skin contact with the enuresis alarm.This device should be looked into.Ref reports mw5080969 and mw5080970.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL ; lowdham, nottingham NG147 EJ; UK NG147EJ
• MDR Report Key: 8024089
• MDR Text Key: 125762842
• Report Number: MW5080971
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 7 YR