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

Model Number M05

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530)

Event Date 11/17/2016

Event Type  Injury  

Event Description

I am really disturbed and disappointed with the quality of malem alarm and the (b)(6) store.When i called the company, i was told that i could buy the malem alarm from the (b)(6) store website and get reimbursement from my healthcare which was a lie as the alarm is not covered by health insurance in (b)(6).Then i contacted the company who refused to return the alarm.With no option left, i used the alarm on my (b)(6) son.The third night of use, the alarm overheated and burnt my son.The alarm got hot and the batteries on the back of the alarm leaked out and the alarm unit.The battery door that houses the alarm unit melted and burnt a hole in my son's t-shirt.My son's neckline was scarred and i had to rush him to the hospital at night.His scars are still there, even after 5 months and it's terrible for a (b)(6) to have to go through this.I have pictures which i can provide if needed.I am surprised why health fda has not intervened as yet.Hope this alarm is not fatal to anyone.A recall is mandatory and i hope the fda acts on it soon.I have also reported this to health (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6521788
• MDR Text Key: 73802843
• Report Number: MW5069310
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M05
• 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: 7 YR