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

Model Number M04SC

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problems Pain (1994); Rash (2033); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 07/30/2018

Event Type  Injury  

Event Description

Last night, my daughter had to be admitted to the hospital.She was sleeping in her room and was using the new bedwetting alarm.It exploded at night and she was crying loudly.She was burnt in her neck from the explosion.The battery also leaked from the alarm and touched her skin where she was burnt.This combined together to cause severe pain and skin rash like conditions.She had an allergic reaction to the alarm explosion and is too scared to sleep now.This alarm arrived over the weekend and i ordered it new from the mfr's website (malemmedical.Com).

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 7746445
• MDR Text Key: 116067219
• Report Number: MW5078832
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR