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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE ENURESIS
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MALEM MEDICAL LTD MALEM; ALARM, CONDITIONED RESPONSE ENURESIS Back to Search Results
Model Number M04S
Device Problems Leak/Splash (1354); Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 04/09/2020
Event Type  Injury  
Event Description
A malem bedwetting alarm was loaned out to parents by our clinic.The child is (b)(6) (male) and chronic bedwetter.The alarm purchased new from bedwettingstore.Com website.Parents brought back the alarm after one night use and said the alarm overheated and seriously injured child in sleep.The alarm is clearly damaged from excess heat.The batteries have leaked and discharged from short circuiting inside the alarm.The batteries were inserted correctly.The alarm was on child when he was sleeping and not used for more than 30 minutes when the incident occurred.Child is extremely frightened and parents worried.Child has burn marks on neck from the incident.Alarm has been received by us and clearly device failure and not user issue.Fda safety report id#: (b)(4).
 
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Brand Name
MALEM
Type of Device
ALARM, CONDITIONED RESPONSE ENURESIS
Manufacturer (Section D)
MALEM MEDICAL LTD
MDR Report Key9987283
MDR Text Key188971603
Report NumberMW5094224
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 Biomedical Engineer
Type of Report Initial
Report Date 04/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberM04S
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 Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age5 YR
Patient Weight23
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