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 04 report with the FDA on 2006-12-06 for INVERNESS EAR PIERCING SYSTEM * manufactured by Inverness Corp..

Event Text Entries

[543145] Consumer claims to have had ears pierced with the inverness system at a retail vendor in 2006. Sought medical attention for redness and swelling at the piercing site two months later and an oral antibiotic was prescribed. A month later returned for medical attention, at that time an incision and drainage was performed and she was prescribed a new oral antibiotic.
Patient Sequence No: 1, Text Type: D, B5


[7913972] Incident reported to inverness on 6/29/06. Requested add'l info on 6/29/06 and 7/14/06. Add'l info was not rec'd until 10/27/06. Earrings not returned to mfr for eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243569-2006-00009
MDR Report Key792665
Report Source04
Date Received2006-12-06
Date of Report2006-11-15
Date of Event2006-03-07
Date Mfgr Received2006-06-29
Date Added to Maude2006-12-12
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 ContactHELENE BERNSTEIN
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 Received2006-12-06
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key780305
ManufacturerINVERNESS CORP.
Manufacturer Address17-10 WILLOW ST. FAIR LAWN NJ 07410 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-12-06

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