MAUDE Adverse Event Report: RODGER RODGER WIRELESS BEDWETTING ALARM

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Rash (2033); Shock (2072); Burn, Thermal (2530)

Event Date 04/17/2017

Event Type  Injury  

Event Description

My son is a persistent bedwetter.We had initially ordered a wet call system.After placing the order, the reps at the bedwetting store told us that we could upgrade to the rodger wireless bedwetting alarm for no additional price.So, we purchased it.The underwear is like a cage full of wires and there is a transmitter part that clips on to it.The receiver is plugged into the wall.The problem started when my son would wet.He would get tiny shocks at night from the underwear.He told us that on the second week.Shocks caused redness around his private area and we had to visit his doctor.I immediately discontinued use of the alarm and emailed the bedwetting store.They said i could not return the alarm as its already been used, even if it is defective it does qualify for return.The product does have a very serious problem that it shocks my son when it is wet.The sensor is supposed to detect wetness.But causing a rash on his privates and thighs is a very serious thing.You should take a look at how seriously it burnt my child one night.He was admitted to the hospital and is still recovering.It is a very dangerous product.(b)(4).

• Brand Name: RODGER WIRELESS BEDWETTING ALARM
• Type of Device: RODGER WIRELESS BEDWETTING ALARM
• Manufacturer (Section D): RODGER
• MDR Report Key: 6519150
• MDR Text Key: 73687352
• Report Number: MW5069276
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• 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): Hospitalization; Life Threatening
• Patient Age: 6 YR
• Patient Weight: 28