MAUDE Adverse Event Report: MALEM MALEM ALARM CONDITIONED RESPONSE ENURESIS; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problems Pain (1994); Choking (2464)

Event Date 01/25/2018

Event Type  Injury  

Event Description

My daughter is going to turn (b)(6) next month, and i got a malem bedwetting alarm to help her stop wetting and train her.I set it up on her and put her to sleep.She disconnected the alarm on her own and started playing with it.She removed the battery cover and put it into her mouth and then swallowed it whole.She was choking on it when i reached there.I immediately put my fingers in her mouth and force it out while it was stuck in her neck.She was in excruciating pain.I am grateful to reach there on time or it would have been fatal.

• Brand Name: MALEM ALARM CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7227659
• MDR Text Key: 98644645
• Report Number: MW5074934
• 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: 01/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR