MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BEDWETTING ALARM

Lot Number M04

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Fumes or Vapors (2529); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 12/27/2017

Event Type  Injury  

Event Description

Purchased a malem bedwetting alarm from the internet at the recommendation of a physician.The device arrived last week and had a defect since the first use.As soon as batteries were inserted, the device makes a clicking and hissing noise and starts getting warm.As time went by, the device kept getting warmer and warmer till it was so hot that my daughter cried out in pain.She was wearing the device at the time.She was smart enough to pull it off her dress.After that, the alarm just literally exploded and started fuming like it caught fire.This could have hurt my daughter very seriously if she had not pulled it off immediately.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham, gb
• MDR Report Key: 7156766
• MDR Text Key: 96225388
• Report Number: MW5074307
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: M04
• Was Device Available for Evaluation?: Yes
• 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): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 18