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

Model Number M05

Device Problem Temperature Problem (3022)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 12/10/2018

Event Type  Injury  

Event Description

My daughter has suffered from skin burns when she was using her malem bedwetting alarm.It has been happening for a few days and i have noticed a small red patch of her neck at night when she uses the alarm.At first i thought it was just rash, but now after a week, i realized that it was actually the heat from the plastic that has scarred my daughter's skin.It is only getting worse, and pinkish scars are growing.Discontinued using the alarm and will return to the mfr.It's getting hot every time it's used.Defective device.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8164784
• MDR Text Key: 130476493
• Report Number: MW5082140
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 30