MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC PHYSICIAN'S CHOICE; EAR PROTECTOR

Model Number 69876

Device Problem Use of Device Problem (1670)

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

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

The product label states: "warning: use whole ear plug.Cover ear canal only.Do not force ear plug into ear canal!" "warning: consult a physician before using ear plugs for any medically related condition.Children should be supervised by an adult when using any ear plugs.Keep ear plugs out of reach of small children and infants.These ear plugs are non-toxic, but may interfere with breathing if accidently caught in the throat, which may cause serious injury or death.Do not use for swimming or diving to depths greater than 10 feet." "warning: carefully ue ear plugs only as directed for effective, problem-free ear protection.".

Event Description

Customer stated the ear putty crumbled in their child's ear canal during first use of the product.Surgical extraction was required to remove the ear putty.The child experienced bleeding and discharge from the ear after removal.

• Brand Name: PHYSICIAN'S CHOICE
• Type of Device: EAR PROTECTOR
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; 11750 12th ave s; burnsville MN 55337
• Manufacturer Contact: paxia her ; 11750 12th ave s; burnsville, MN 55337 ; 9528088364
• MDR Report Key: 8933125
• MDR Text Key: 155780556
• Report Number: 0002183416-2019-00007
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 69876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention