MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC KIDS KROGER SILICONE EAR PLUGS

Model Number C265STKG

Device Problem Use of Device Problem (1670)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2018

Event Type  Injury  

Manufacturer Narrative

The package label provides the following information: "these ear plugs are sized to cover tiny ear canals only - use our adult size to cover larger ear canals.Directions for effective and comfortable use: with clean hands, roll plug between fingers to soften.Use entire plug.Shape plugs into a ball.Place plugs against ear openings and flatten firmly.Just cover ear opening.Do not force into ear canal.Safety warnings: not recommended for overnight use, diving, prolonged underwater swimming, or depths over 10 feet.Although these plugs are not intended for use as hearing protectors, they will help block sound when properly sealed.In case of airplane use, remove prior to descent.If you should experience pain or discomfort when using this product, please discontinue use.Caution: inspect product before use and replace plugs if they are damaged or show signs of wear.Not for prolonged use.Do not cut, stretch or break apart ear plugs.If not used as directed, ear plug could become trapped in ear canal requiring surgical removal by a qualified professional.If ear plug has become lodged in ear canal, do not try to remove with tweezers or any other device.Seek medical attention for proper removal.Please note - a few days delay will cause no harm.Warning: keep ear plugs away from infants and small children as they may get caught in the windpipe and create a choking hazard.Use by children should be closely supervised by adults.".

Event Description

User's guardian stated after use of the silicone earplug, it could not be removed from the user's ear canals and kept breaking apart upon removal.The user's guardian stated they tried using tweezers to remove the ear plugs.The user went to the emergency room where suction methods were used to try to remove the silicone ear plugs.The user had to get the silicone ear plugs surgically extracted with anesthesia for removal from the ear canals.

• Brand Name: KIDS KROGER SILICONE EAR PLUGS
• Type of Device: SILICONE EAR PLUGS
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; 11750 12th ave s.; burnsville MN 55337
• Manufacturer Contact: russ davies ; 11750 12th ave s.; burnsville, MN 55337 ; 9528088365
• MDR Report Key: 7974233
• MDR Text Key: 123987230
• Report Number: 0002183416-2018-00001
• Device Sequence Number: 1
• Product Code: EWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: C265STKG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR