MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M04

Device Problems Device Alarm System (1012); Melted (1385); Overheating of Device (1437); Structural Problem (2506)

Patient Problems Erythema (1840); Scarring (2061); Superficial (First Degree) Burn (2685)

Event Date 09/17/2015

Event Type  Injury  

Event Description

I purchased a malem bed-wetting alarm for my daughter from the website (b)(6).The product came to me was new (at least appeared to be new) but the packing was not sealed.I inserted batteries in the unit and powered it on.My daughter went to bed with the alarm and in the middle of the night screamed out loudly.She cried and we went running to her.The alarm piece that connects to the t-shirt had partly melted from the back.The piece was so hot that it burnt a hole through my daughter's t-shirt, melted and her skin near her neck was red.She had a scar.On close inspection, we realized that the product has a vibration feature which was turned on and the poor mfg quality of the alarm led to the vibration motor getting stuck and overheating the system.It's shocking and disappointing that there is no auto-shut off or mechanism for children's safety built into this product.The back of the alarm has partially melted and burnt through my daughter's t-shirt and also left a burn mark near her neck where the alarm is placed.Calls to the company's support team were not answered the following day.I have read on the internet and this appears to be a problem with the product reported by other parents as well.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 5104706
• MDR Text Key: 26837997
• Report Number: MW5056480
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 09/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• Device Catalogue Number: NONE
• Other Device ID Number: NONE
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22