MAUDE Adverse Event Report: Q-GRIP; EAR IRRIGATION KIT

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

Patient Problems Hearing Loss (1882); Tissue Damage (2104)

Event Date 05/13/2020

Event Type  Injury  

Event Description

Hi, i used this product and it damaged/scratched my eardrum.I couldn't hear for a few days after using it.Saw my doctor who prescribed rest and quiet sounds.It doesn't seem to be fda approved for treatment even though it claims to be.(b)(4).My md said i scratched but didn't perforate my eardrum.This product should be illegal, period.(b)(4).Fda safety report id# (b)(4).

• Brand Name: Q-GRIP
• Type of Device: EAR IRRIGATION KIT
• MDR Report Key: 10061459
• MDR Text Key: 191292439
• Report Number: MW5094519
• Device Sequence Number: 1
• Product Code: OGQ
• 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
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 84