KROGER SILICONE EAR PLUG K10-67

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-17 for KROGER SILICONE EAR PLUG K10-67 manufactured by Apothecary Products, Llc.

Event Text Entries

[124062500] Apothecary products was acquired in february 2014 following which a new management team was established. This included a new regulatory and quality systems team. As part of this transition a regulatory and quality system compliance assessment was conducted, which included a three-year retrospective review of complaints from 1 january 2014 to 31 may 2018 to ensure that reported events that meet the reporting requirements of 21 cfr part 803 medical device reporting (mdr) regulation were notified to the fda. During this review, we identified 5 complaints that we believe meet the reporting criteria which were not reported to the fda and are being reported to the fda at this time. New procedures have been implemented to ensure that events that meet the reporting criteria requirements of 21 cfr part 803 are reported to the fda in accordance with regulatory requirements.
Patient Sequence No: 1, Text Type: N, H10


[124062501] User stated that while using the silicone ear plug in the shower, it "came apart" in his ear. His wife attempted to remove the silicone ear plug with a tweezer. User went to the doctor to have the silicone ear plug removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002183416-2018-00003
MDR Report Key7974092
Report SourceCONSUMER
Date Received2018-10-17
Date of Report2018-10-16
Date of Event2015-06-01
Date Mfgr Received2015-06-25
Date Added to Maude2018-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. PAXIA HER
Manufacturer Street11750 12TH AVE S.
Manufacturer CityBURNSVILLE MN 55337
Manufacturer CountryUS
Manufacturer Postal55337
Manufacturer Phone9528088364
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKROGER SILICONE EAR PLUG
Generic NameSILICONE EAR PLUGS
Product CodeEWD
Date Received2018-10-17
Model NumberK10-67
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPOTHECARY PRODUCTS, LLC
Manufacturer Address11750 12TH AVE S. BURNSVILLE MN 55337 US 55337


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-17

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