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

Model Number M04S

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Scarring (2061); Caustic/Chemical Burns (2549)

Event Date 01/08/2018

Event Type  Injury  

Event Description

I am surprised and disappointed that my (b)(6) daughter has been injured and hurt by the use of a bedwetting alarm.The product was recommended by her dr who said it would stop her nighttime setting.It was purchased from (b)(6) and was received this week.The alarm was acting abnormally since we received it.As soon as batteries are put inside the alarm the alarm gets hot.I thought that it was temporary and that once it got warm from normal operation, and would remain that way.I clipped it on my daughter near her neck at night and put her to bed.It took just 20 mins for the alarm to literally explode and batteries leaked out.The hot battery acid leaked on to my daughter's neck and bruised her very badly.She had to be treated by drs for the chemical burns and they put her under observation for a few days.We have visited the clinic daily for f/u.Her burns are bad and become scars.The dr says that the red scars will heat over time.Till then, we are afraid to use another product like this.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7199257
• MDR Text Key: 97643349
• Report Number: MW5074590
• 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: 01/13/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• 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: 20