• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MACK'S / MCKEON PRODUCTS, INC. MACK EAR PLUG; PROTECTOR, HEARING (INSERT)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MACK'S / MCKEON PRODUCTS, INC. MACK EAR PLUG; PROTECTOR, HEARING (INSERT) Back to Search Results
Device Problem Break (1069)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 12/10/2020
Event Type  Injury  
Event Description
How to report ear plugs that are putty like and come apart in your ear and are nearly impossible to remove.Macks brand that are sold at (b)(6), on (b)(6), and many other places.All of the silicon pliable earplugs need to be removed from shelves.Not traditional earplugs such as those for construction.They are supposedly for the outside of your ear and are supposedly water proof.They do not work unless pushed into the ear and then pieces come off into the ear when trying to take them out.It is a putty like, play doh like substance that is smoother when pushed together, but still comes apart like play doh does.Please recall them and remove them from shelves.My ear still is having difficulty weeks later.Please and thank you.I am not sure if this product is approved by federal laws.Many products now a days do not have patents, trademarks, and copyrights.The products are cheaper and sometimes still a good product.However, it must be unfair to the original product maker who properly registered their business product and assumed they would not be unfairly copied.Is it a federal requirement to register new products with the patent office and i think it ought to be to keep things fair for everyone.If i owned a business and some online sight came along using unfair delivery practices such as (b)(6) i would be upset because (b)(6) needs to use the united states federal post office and use federal regulated delivery procedures; it is not legal to deliver items that have no return address as to whom ordered the item to be sent to a residence resulting in fraudulent activity such as false positive tests and other harassing content that if it is not federally regulated by the united states of america it is never just one person who is a victim in all situations there is always many instances that go unreported due to lack of available knowledge of how to do so and out of fear of retaliation.I think fear of retaliation is a huge factor in those who practice unethical business practices to cut corners and save money while increasing profit margins and taking the place of traditional businesses that are legitimate and that you would never ever in a hundred years receive a bad product from.The government regulations protect us from many citizens rights being violated.Privacy, safety, guarantee of appropriate item being delivered undamaged, and many other factors such as fair pricing.My concern is that (b)(6) needs to stay in business because it has bought up many products, we may not be able to find in stores such as (b)(6) and it is hard to regulate home to home sales over the internet with a non-regulated delivery system and it is unfair to the public for this to go unreported.Keep (b)(6), and regulate them, require them to use the post office delivery system, no exceptions.Their trucks do not have windows and the employees do not have uniforms violating proper protocol, and with noise violations, and inappropriate trespassing at times with the wrong packages.Due to the hours they delivery at anytime of the night and day it is easy for the wrong items to be delivered to harass and intimidate victims of other situations and or just because there is something wrong with someone¿s sense of humor or something else.I am not an expert on criminal mind set and however, i also cannot relate to or explain them, and it needs to be taken seriously because i will sit around with the knowledge, i could report something and thankfully can type and not do anything about it for others if not only for myself.Which i could ignore it and not tell anyone and then not get in trouble for the wrong deliveries and however, for that exact reason it needs to go through the united states post office during delivery hours and days only, with no exceptions for screening of boxes and items, and whom sent them.Thank you for your patience and understanding.Hope your holidays were wonderful.(b)(6).Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MACK EAR PLUG
Type of Device
PROTECTOR, HEARING (INSERT)
Manufacturer (Section D)
MACK'S / MCKEON PRODUCTS, INC.
MDR Report Key11163388
MDR Text Key227036513
Report NumberMW5098796
Device Sequence Number1
Product Code EWD
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/10/2021
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/12/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
Patient Weight5
-
-