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

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 04/27/2017

Event Type  Injury  

Event Description

Purchased the malem bedwetting alarm from (b)(6) website.The first night of use, the alarm literally exploded and burnt (b)(6) neck.It was a very serious burn and we had to seek prompt medical attention.(b)(6) was rushed to the emergency room and treated for serious burns to her neck.She still has burns from that day on her neck.If i had not intervened, this could have been potentially lethal.The back of the alarm unit completely melted and there was a big hole in her t-shirt.The batteries have leaked completely.Photos are available and so is the product.

• Brand Name: MALEM BEDWETTING ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6543758
• MDR Text Key: 74618113
• Report Number: MW5069565
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 24