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

Model Number M04S

Device Problems Leak/Splash (1354); Explosion (4006)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 03/20/2019

Event Type  Injury  

Event Description

My daughter was sleeping at night with her bedwetting alarm when she cried out in pain.The alarm exploded at night and burnt her.This has had a fractured experienced on her.She is terrified to use the alarm now and continues to wet the bed.We are also very worried about using alarms.The alarm was purchased new and was used with batteries that came with the alarm.It was barely used 1 night for 2 hours and it leaked batteries and got too hot and burnt my daughter's skin.Fortunately, we checked on her in her sleep or this could have been more harmful.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDIITONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8479525
• MDR Text Key: 140944528
• Report Number: MW5085543
• 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: 03/29/2019

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 Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR