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

Model Number M042

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Component (2292)

Patient Problems Shock (2072); Depression (2361); Superficial (First Degree) Burn (2685)

Event Date 12/16/2019

Event Type  Injury  

Event Description

Our office has loaned out an enuresis alarm to a pt for treatment of primary nocturnal enuresis.The pt was a (b)(6) y/o girl diagnosed with autism.Parents were instructed on use of alarm.Alarm was new.Parents used alarm and reported burns to pt's skin within 30 mins of using the alarm.Pt was scared and no fault of pt.Alarm malfunctioned and caused injuries.The cause was likely a defect in alarm which caused it to overheat and short out the batteries.Parents claimed that the alarm had battery acid leak on the underside and was on high temperature.We reached out to the mfr for explanation several times, but have not received any response.Our observation is that the alarm is defective.Pt was asleep when incident occurred.No fault of parents or pt.Alarm was used correctly.Child has first degree burns on chest and being treated for shock and depression.Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham NG14 G8; UK NG14 G8
• MDR Report Key: 9524230
• MDR Text Key: 173042567
• Report Number: MW5091897
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: ULTIMATE BEDWETTING ALARM
• 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 Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 24