MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 01/11/2019

Event Type  Injury  

Event Description

The intent of the report is to report three similar incidents which resulted in children getting injured at night in their sleep while using the malem bed wetting alarm device.The three incidents took place on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.The age of the user was (b)(6) years in two cases and (b)(6) years in the other case, in each case, the malem alarm was purchased new from the mfr's website and used only for 1 night.The alarm overheated at night when the child was sleeping.The alarm has burnt the child's skin when they were asleep.We have discontinued recommending this alarm to pts.The alarms have been returned back to mfr for inspection.The cause of the failure is likely an electrical short that caused the device to generate excess heat and leak batteries which spread on the child's body.The children were treated for first degree burns and discharged.A new bed wetting alarm was recommended, but parents have decided not to continue treatment.Ref report numbers: mw5086096 and mw5086116.Fda safety report id# (b)(4).

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8546160
• MDR Text Key: 143241497
• Report Number: MW5086115
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• 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): Hospitalization