MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Device Problems Melted (1385); Product Quality Problem (1506)

Patient Problem Burn(s) (1757)

Event Date 10/11/2017

Event Type  Injury  

Event Description

I am shocked to see that the fda is allowing dangerous products to be sold for children here in the us market.My (b)(6) son was badly hurt with the malem bedwetting alarm when we used it on to stop his bedwetting.The quality of the alarm is so poor that the back of the alarm melted and burnt my son's neck.We rushed to the hospital to treat him.I purchased this malem ultimate alarm from (b)(6).This is an extremely unsafe product and must be pulled off the market.I also request the fda to inspect the malem medical (who is the manufacturer of the product) for quality and safety.The manufacturer resides in the (b)(4) (a simple search on (b)(6) will get you the manufacturers details).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6964344
• MDR Text Key: 89933371
• Report Number: MW5072844
• 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: Unknown
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR