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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL ALARMS BEDWETTING ALARM
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MALEM MEDICAL MALEM MEDICAL ALARMS BEDWETTING ALARM Back to Search Results
Model Number M04
Device Problems Melted (1385); Device Slipped (1584); Temperature Problem (3022)
Patient Problems Erythema (1840); Pain (1994); Discomfort (2330)
Event Date 06/23/2017
Event Type  Injury  
Event Description
I purchased a malem ultimate bedwetting alarm on (b)(6) for my son and i have serious concerns about the safety of this product."is it even safe for children's use." this product is absolute garbage, cheaply made and very flimsy.The compartment that holds the batteries did not hold the batteries securely so we put duct tape to hold it in place.After six hours of use in the night, it got very hot and the battery door melted.My son got a big red scar on his neck causing him lot of pain and discomfort and unnecessary dr's visits and made us feel horrible for choosing this kind of useless product.Thank god we intervene or it would be a complete disaster.We are now terrified of ever using anything like that.
 
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Brand Name
MALEM MEDICAL ALARMS BEDWETTING ALARM
Type of Device
BEDWETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL
lowdham, nottingham NG14 7EJ
UK  NG14 7EJ
MDR Report Key6669289
MDR Text Key78501797
Report NumberMW5070621
Device Sequence Number1
Product Code KPN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 06/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age8 YR
Patient Weight34
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