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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM
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MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM Back to Search Results
Model Number M04SC
Device Problems Fluid/Blood Leak (1250); Melted (1385); Overheating of Device (1437)
Patient Problems Erythema (1840); Scarring (2061); Reaction (2414); Burn, Thermal (2530)
Event Date 03/21/2018
Event Type  Injury  
Event Description
My husband purchased a bedwetting alarm for our (b)(6) daughter from (b)(6).It arrived 3 days ago and we used it on her for the first time on (b)(6), we put it on her and went to bed.About 30 mins to an hour later, she came to our room crying and complaining about how the alarm had burnt her.We examined her cause the alarm was still stuck on her shirt and she was holding it away from her body.The alarm was very hot, so hot that it could have burnt her which it did.The batteries inside the alarm leaked out and spread all over her body.She had a reaction to the battery leak and her skin had turned red from burns.We took her to the medical center and they treated her.We are too afraid to use this type of product again in the future.It has burnt a child who was sleeping at night and caused scarring.
 
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Brand Name
MALEM ULTIMATE BEDWETTING ALARM
Type of Device
MALEM ULTIMATE BEDWETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL
MDR Report Key7372901
MDR Text Key103604946
Report NumberMW5076104
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04SC
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/26/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age6 YR
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