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 2006-02-13 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..

Event Text Entries

[451594] Consumer claims to have had his ears pierced at a retail vendor with the inverness system in 2003. Sought medical attention for redness and swelling at the piercing site in 01/2004. Oral antibiotics were prescribed at that time. Sought medical attention again in 01/2004 and was admitted to the hospital at that time in 01/2004 an incision and drainage was performed and i. V. Antibiotics were administered. A repeat incison and drainage was performed four days later and i. V. Antibiotics were continued. She was discharged, after three days and oral antibiotics were prescribed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243569-2006-00001
MDR Report Key675837
Report Source00
Date Received2006-02-13
Date of Report2006-02-08
Date of Event2003-12-27
Date Mfgr Received2004-09-24
Date Added to Maude2006-02-16
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 CodeJXS
Date Received2006-02-13
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 Key665120
ManufacturerINVERNESS CORP.
Manufacturer Address17-10 WILLOW ST. FAIR LAWN NJ 07410 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-02-13

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