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

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 12/12/2017

Event Type  Injury  

Event Description

We bought the malem ultimate alarm for my son from the bedwetting store.On day one itself the alarm overheated and burnt my child at night while he was asleep.The burns are severe.He had to be rushed to the hospital for treatment.Till date he is in pain and we can see a red patch on his neck, we are applying medication every day as recommended.I hope he gets over his pain and his scar gets off soon.I really expect the fda to look into this product and take necessary action.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7133813
• MDR Text Key: 95470762
• Report Number: MW5074117
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2017

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR