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

Model Number M04

Device Problem Overheating of Device (1437)

Patient Problem Scarring (2061)

Event Date 01/23/2019

Event Type  Injury  

Event Description

Last night , my daughter used a bedwetting alarm for the first time.It was prescribed by her pediatrician.Unfortunately, the alarm has a severe defect which causes it to get hot when my daughter is sleeping.It is strange because the alarm should be connected to her at sleep.Heating up is not an option and not normal.Within an hour of sleeping, her alarm heat up and scarred her chest and neck region.She is older and was able to remove it before any additional damage was caused.We treated her at home.The alarm is still in our possession.It is erratic.After last night, i have checked it with different set of batteries and it is getting hot every time it is operated.Not normal and definitely not safe.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham ; UK
• MDR Report Key: 8286362
• MDR Text Key: 134607955
• Report Number: MW5083440
• 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
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• 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 Age: 8 YR