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

Model Number M042

Device Problems Leak/Splash (1354); Loss of Power (1475); Self-Activation or Keying (1557); Defective Component (2292); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 05/18/2019

Event Type  Injury  

Event Description

Last night, son¿s malem bedwetting alarm failed in the middle of the night and caused a minor burn on his skin.After being diagnosed with bedwetting, we bought this alarm with high hopes and it was the first night that we used the alarm.It came with all instructions and batteries, however it is defective.My son went to bed at 10 pm and by 10:40 pm, we heard him screaming in his room.Frightened, we ran and found him crying.He was tugging on his shirt and said the alarm was too hot and burning him.I was also unable to remove the alarm because it was too hot and burning my fingers.I removed his shirt and was in pain from the burn.Pinkish patches on his neck from the alarm.The alarm eventually shut itself off and batteries leaked out.I have taken him to the clinic for treatment and left the alarm with them.We had a scare at night from using this defective alarm.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8628505
• MDR Text Key: 145667807
• Report Number: MW5086797
• 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: 05/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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: M SERIES
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 20