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 2007-07-03 for INVERNESS EAR PIERCING SYSTEM manufactured by Inverness Corp..

Event Text Entries

[657191] Consumer claims to have had ears pierced at a retail vendor with the inverness system in 2005. Sought medical attention for redness and swelling at the piercing site on ten days later. An oral antibiotic was prescribed at that time. Sought medical attention again on the following month, and was admitted to hospital overnight, where an incision and drainage was performed. Discharged on the next day with oral antibiotic prescribed.
Patient Sequence No: 1, Text Type: D, B5


[7807966] Incident reported to inverness in 2006. Requested information on 11/20/2006 and 12/05/2006. Information not received until 05/29/2007.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243569-2007-00002
MDR Report Key874942
Report Source00
Date Received2007-07-03
Date of Report2007-06-14
Date of Event2005-08-13
Date Mfgr Received2006-11-10
Date Added to Maude2007-12-27
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 FDA0
Event Location0
Manufacturer ContactHELENE BERNSTEIN
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
Product CodeJYS
Date Received2007-07-03
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key938024
ManufacturerINVERNESS CORP.
Manufacturer AddressFAIR LAWN NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-07-03

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