FLENTS KID'S SILICONE EAR PLUGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-05 for FLENTS KID'S SILICONE EAR PLUGS manufactured by Apothecary Products, Inc..

Event Text Entries

[861459] Father put ear plugs in ears of an autistic and blind child for bath on instructions of doctor due to recent adenoidectomy. This had been procedure for past 2 months. This last time was using the first usage of the last pair of ear plugs in the package. After bath the child would take the plugs out and hand them to the dad who would put them aside for next usage. In 2008, the right ear plug came apart and a good portion of the plug remained in the ear canal. Mother tried to remove it with tweezers, but the plug came apart in tiny pieces, so we took child to emergency room where after 90 minutes of horror the plug was finally removed by the er doctor. Photos enclosed showing the tiny particles which were removed from child's ear. Doctor remarked that the plug had the consistency of cheese. This caused much pain for the child and concern for the parents. Doctor prescribed antibiotic ear drops the next few days for child and make appointment with ent doctor soon as possible. The next day, father called the company to let them know event. Spoke to person who wanted sample of plug sent to company. Copy of this report included with sample.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007227
MDR Report Key1058369
Date Received2008-06-05
Date of Report2008-06-05
Date Added to Maude2008-06-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFLENTS KID'S SILICONE EAR PLUGS
Generic NameSILICONE EAR PLUGS
Product CodeEWD
Date Received2008-06-05
Lot NumberC265
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1027486
ManufacturerAPOTHECARY PRODUCTS, INC.
Manufacturer AddressMINNEAPOLIS MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-06-05

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