MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number N04SC

Device Problems Burst Container or Vessel (1074); Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 09/19/2017

Event Type  Injury  

Event Description

I am a pediatrician with hospital (b)(6) in (b)(6), and i have been recommending enuresis alarms to my pts for several years.Though not very effective, they have better success than some other alternatives.I purchased the malem enuresis alarm from usa on my most recent trip for my (b)(6) daughter.She has been battling primary nocturnal enuresis for several years and this alarm was one i found through a regular internet advertisement.The alarm was purchased by me from the mfr's website (b)(6) and a new product was received by me.My daughter tried the alarm for the first time on (b)(6).I know how to set up this alarm and operate it.I did exactly that.Within 45 minutes of placing it on my daughter, she came downstairs to the living room crying.I noticed that the batteries inside the alarm had exploded and leaked all onto her clothes.The batteries leak was very severe.The battery acid had spilled on to her clothes and gone to her chest and neck.From the acid irritation, she had burn marks on her body.I had to administer first aid treatment on my daughter and then took her to the clinic for f/u.From the heat produced, the back casing of the alarm has partially melted as well.The alarm is available for inspection by the fda if needed.This is an unsafe and dangerous product for children.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 6893738
• MDR Text Key: 87459517
• Report Number: MW5072414
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N04SC
• 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): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 19