INVERNESS EAR PIERCING SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-04-01 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..

Event Text Entries

[410781] Consumer claims to have had ears pierced with the inverness system at a retail vendor in january 2003. Sought medical attention for redness and swelling at the piercing site in 02/2003. They received an oral antibiotic at that time. They returned for incision and drainage in 02/2003 and 03/2003. They were prescribed a new oral antibiotic in 03/2003 and had another incision and drainage in 03/2003.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243569-2005-00007
MDR Report Key587295
Report Source00
Date Received2005-04-01
Date of Report2005-03-30
Date of Event2003-01-17
Date Mfgr Received2003-09-09
Date Added to Maude2005-04-05
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 Location0
Manufacturer ContactJILL TYLICKI
Manufacturer Street17-10 WILLOW STREET
Manufacturer CityFAIR LAWN NJ 07410
Manufacturer CountryUS
Manufacturer Postal07410
Manufacturer Phone2017943400
Manufacturer G1INVERNESS CORPORATION
Manufacturer Street17-10 WILLOW STREET
Manufacturer CityFAIR LAWN NJ 07410
Manufacturer CountryUS
Manufacturer Postal Code07410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVERNESS EAR PIERCING SYSTEM
Generic NameEAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS
Product CodeJYS
Date Received2005-04-01
Model NumberNA
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key577142
ManufacturerINVERNESS CORP.
Manufacturer Address17-10 WILLOW STREET FAIR LAWN NJ 07410 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-04-01

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