MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BED-WETTING ALARM

Model Number M04S2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Choking (2464)

Event Date 05/27/2016

Event Type  Injury  

Event Description

Last night, my son was using a malem bed-wetting alarm and accidently swallowed the battery door on the product.My son is (b)(6) years old and we purchased the product from the website (b)(6).We spoke to the customer support rep who said that 2 years is the ideal age to start using the bedwetting alarm.We purchased it and used it for 3 nights before this happened.My child choked on the battery door and i am frustrated that this happened.Shouldn't the company have a marking or sell products to older children? i have also raised this complaint with the company directly but haven't heard back from them.Shame on this company for making horrible products.It could have killed my child.My child choked.We had to rush to the emergency room to get him treated.He was bleeding and traumatized after the event.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: MALEM BED-WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 5694338
• MDR Text Key: 46469041
• Report Number: MW5062595
• Device Sequence Number: 1
• Product Code: KPN
• 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: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M04S2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2.5 YR
• Patient Weight: 14