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 2004-03-09 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..

Event Text Entries

[355345] Consumer claims to have had ears pierced with the inverness ear piercing system in 2002. Sought medical attention two weeks later for redness and swelling at the piercing site and was prescribed oral antibiotics. Returned for medical treatment eleven days later and an incision and drainage was performed. At that time pt was sent to the hosp and was admitted. During their hosp stay, another incision and drainage was performed, i. V. Antibiotics were administered, and oral antibiotics were given. Pt was discharged in 07/02 and was continued on oral antibiotics.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2243569-2004-00001
MDR Report Key515496
Report Source00
Date Received2004-03-09
Date of Report2004-03-08
Date of Event2002-06-30
Date Mfgr Received2002-10-22
Date Added to Maude2004-03-15
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 CORP.
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 Received2004-03-09
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 Key504504
ManufacturerINVERNESS CORP.
Manufacturer Address17-10 WILLOW STREET FAIR LAWN NJ 07410 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-03-09

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