MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE PRO ALARM; ALARM, CNDITIONED RESPONSE ENURESIS

Model Number ULTIMATE PRO

Device Problems Melted (1385); Overheating of Device (1437); Material Deformation (2976)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 09/09/2019

Event Type  Injury  

Event Description

Pediatrician had recommended a bedwetting alarm for the treatment of nighttime wetting.After some online search, found malem bedwetting alarm.Alarm has been a complete disaster.Daughter slept with is and she was hurt from the battery explosion that took in the alarm portion.Batteries likely exploded as a result as a result of device malfunction and short.But the plastic also melted and deformed.My daughter was in so much pain with this burn at 2am.It's gone from red to a blister and now it¿s a small scar on the neck.Pediatrician recommended to complain to fda.Daughter is traumatized and shaken up from the alarm and so are we.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE PRO ALARM
• Type of Device: ALARM, CNDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9081978
• MDR Text Key: 159344334
• Report Number: MW5089846
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR