FDA.reportPublic FDA data

MAUDE MDR 639441

MDR report key
639441
Report number
2243569-2005-00017
Event key
0
Event type
3
Date of event
2003-08-24
Date received
2005-10-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
405
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JILL TYLICKI
Address
17-10 WILLOW STREET FAIR LAWN NJ 07410 US
Phone
201-201-2017
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INVERNESS EAR PIERCING SYSTEMEAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGSINVERNESS CORP.JYSNA**NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-10-0401. O

Event Narratives#

D

Patient 1

CONSUMER CLAIMS TO HAVE HAD EARS PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 03. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE THE FOLLOWING DAY. WAS ADMITTED TO THE HOSPITAL AT THAT TIME AND I.V. ANTIBIOTICS WERE ADMINISTERED. WAS DISCHARGED THE FOLLOWING DAY AND WAS CONTINUED ON ORAL ANTIBIOTICS.