MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM ; ALARM, CONDITIONED RESPONSED, ENURESIS

Model Number M042

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Date 08/17/2019

Event Type  Injury  

Event Description

The clip that connects on the sensor is very tight and requires a lot of force.My daughter is 5 and she was having a hard time installing it on her underwear.When she opened the clip, the plastic part broke and hit her in her eye.It's a very thin plastic part that is brittle.It just broke and a large piece hit her.She was crying and we took her to the dr who told us that it was blunt trauma.Her eye is red from the injury.The alarm has been left with the hosp.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSED, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8927211
• MDR Text Key: 155553957
• Report Number: MW5089281
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR