ORAPLUG ORAPLUGPKG-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-13 for ORAPLUG ORAPLUGPKG-10 manufactured by Integra Neurosciences Pr.

Event Text Entries

[2445604] The reporter a dentist stated (pt #4) used the product to fill an extraction socket. A few days after the procedure, the pt developed signs of local infection such as pain and swelling. The pt also developed a late local abscess after extraction of tooth #30 when the product was used. She was treated with an incision and drainage. The healing is within normal.
Patient Sequence No: 1, Text Type: D, B5


[9561919] The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2011-00041
MDR Report Key2378450
Report Source05
Date Received2011-12-13
Date of Report2011-12-13
Date Mfgr Received2011-11-22
Date Added to Maude2011-12-19
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 ContactMARIA D'AGOSTINO
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORAPLUG
Generic NameDENTAL PRODUCTS
Product CodeLPG
Date Received2011-12-13
Catalog NumberORAPLUGPKG-10
Lot Number1112593
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA NEUROSCIENCES PR
Manufacturer AddressANASCO PR 00610 US 00610


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2011-12-13

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