MAUDE Adverse Event Report: BENEFICIAL PRODUCTS INC. MIGHTY PLUGS; PROTECTOR, HEARING (INSERT)

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

Patient Problems Peeling (1999); Blister (4537)

Event Date 03/14/2021

Event Type  Injury  

Event Description

Damaged all skin in the ear; one use of product caused all of the skin to blister and peal inside both ears.Manufacturer contacted, but manufacturer refused to respond to product questions, other than stating they had a similar problems several times previously.

• Brand Name: MIGHTY PLUGS
• Type of Device: PROTECTOR, HEARING (INSERT)
• Manufacturer (Section D): BENEFICIAL PRODUCTS INC. ; po box 3462; ashland OR 97520
• MDR Report Key: 11805379
• MDR Text Key: 250186191
• Report Number: MW5101261
• Device Sequence Number: 1
• Product Code: EWD
• Combination Product (y/n): Y
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 76