MAUDE Adverse Event Report: APOTHECARY PRODUCTS LLC QUIET PLEASE EP; EAR PLUGS

Model Number 69018

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2022, the company was aware that the report was not visible in maude database.After enquiring with fda cdrh emdr representative, we learned there was a technical problem while submitting the file.The company was advised to resubmit this form and to add this statement.Apothecary products llc, quality team has done further research on item 69018 flents quiet please ear plugs and this appears to be an isolated incident where user potentially had latex allergic reaction.The item is not made with natural rubber latex.Our ear plugs are made of pvc material.We contacted our contract manufacturers to see if latex was used in any steps of handling the device, and the answer was no.All the steps involed in manufacturing and packaging of this device are done with gloves which are not made with natural rubber latex, our device does not have latex.

Event Description

Customer used one pair of the ear plugs for sleeping.She developed the allergy.When she woke up both ears were swollen inside the ear canal, particularly the inside right ear.She is allergic to latex but this item says "not made with natural rubber latex." called doctor and he prescribed antibiotic ear drops.

• Brand Name: QUIET PLEASE EP
• Type of Device: EAR PLUGS
• Manufacturer (Section D): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer (Section G): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer Contact: pankaj jitiya ; 11750 12 th avn south; burnsville, MN 55337 ; 9528088330
• MDR Report Key: 14279580
• MDR Text Key: 290704778
• Report Number: 0002183416-2022-00002
• 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: 05/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 69018
• Device Catalogue Number: 69018
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 05/04/2022
• 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 Sex: Female