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

Model Number M042

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

Patient Problems Pain (1994); Scarring (2061); Burn, Thermal (2530)

Event Date 05/13/2019

Event Type  Injury  

Event Description

Malem alarm burnt my son's t-shirt and skin.His neck is scarred from hot alarm.The alarm was only used 1 time and that night, when he was sleeping, the alarm detected his bedwetting but did not beep and wake him up.He slept through it.Meanwhile, the alarm got hot and burnt him.By the time i checked on him, he was in pain and the batteries leaked from the underside of the alarm.The burns are not serious, but they are scary for us and we stopped using the alarm.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED, RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8655434
• MDR Text Key: 146674099
• Report Number: MW5087008
• 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: 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: M042
• Device Lot Number: ULTIMATE ALARM FOR BEDWETTING
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR