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

Model Number MALEM BLUE ALARM FOR BOYS

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 07/26/2019

Event Type  Injury  

Event Description

Used the alarm for 3 nights and every night, the sensor came off from the underwear.On the last night of use, the clip broke from the sensor and the metal plates that are connected on the sensor got exposed.As my son moved in bed, the metal plates cut his inner thighs and caused sufficient bleeding.Metal plates are too sharp and when exposed, potentially dangerous for use.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8861168
• MDR Text Key: 153404016
• Report Number: MW5088741
• 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: 07/31/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM BLUE ALARM FOR BOYS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR