HYDROSIL 625340

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 2006-01-20 for HYDROSIL 625340 manufactured by *.

Event Text Entries

[416992] A pt claims to have developed a rash, pimples, burning sensations, and later sores/lesions on the face in the area where hydrosil xt contacted the skin during an impression procedure. The pt noted the symptoms began to develop a short time after the procedure and had been present for approx ten months at the time the event was reported. Two doctors were consulted and the pt was administered antibiotics, steroids, and a burn cream to treat the symptoms. Additionally, a biopsy was performed on the area and the symptoms classified as a "chemical/sun irritation reaction. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515379-2005-00540
MDR Report Key666024
Report Source00
Date Received2006-01-20
Date of Report2005-12-23
Date of Event2005-02-15
Date Mfgr Received2005-12-23
Date Added to Maude2006-01-24
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 ContactDR. PATRICIA KIHN
Manufacturer Street221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CTR W
Manufacturer CityYORK PA 17404
Manufacturer CountryUS
Manufacturer Postal17404
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 W. CLARKE AVE
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDROSIL
Generic Name*
Product CodeEBH
Date Received2006-01-20
Model NumberNA
Catalog Number625340
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key655395
Manufacturer*
Manufacturer Address* * *
Baseline Brand NameHYDROSIL
Baseline Generic Name*
Baseline Model NoNA
Baseline Catalog No625340
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-01-20

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