MAUDE Adverse Event Report: MALEM MEDICAL / BEDWETTING STORE MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Product Quality Problem (1506)

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 09/10/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm attaches to the pajama top with the help of a safety pin which is a part of the product.It just so happened that while he was asleep the safety pin at the back of the malem bedwetting alarm went into his chest.He screamed out loud and i could see blood on his pajama top and i gradually pulled the pin out.I noticed that the safety pin had 1 inch of blood on it, which means it had gone 1 inch into my son's chest.We had to rush him to the doctor who applied medication and gave him a tetanus shot.This kind of substandard quality is unacceptable.If this can happen to my son, it can happen to other children out there.I would like the fda to deal with the mfr to call back all products as the safety pin is unsafe.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL / BEDWETTING STORE
• MDR Report Key: 6857628
• MDR Text Key: 86009425
• Report Number: MW5072097
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 09/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR