N-TRALIG INTRLGMNTRY SYRG 76-55

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-25 for N-TRALIG INTRLGMNTRY SYRG 76-55 manufactured by Integra York, Pa Inc..

Event Text Entries

[91198573] 10/16/17 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - the customer supplied pictures indicate necrotic tissue at injection site. The cause for the necrotic tissue can not be determined as the needle, lidocaine, and process during the procedure is not known. The complaint is confirmed. Device history evaluation - any applicable nonconforming product report / nonconforming material report history: none. Any applicable variance authorization / deviation history: none. Any applicable engineering change order / manufacturing change order history: none. Any applicable corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the customer supplied pictures indicate necrotic tissue at injection site. Root cause undetermined. There has been no manufacturing deficiency identified.
Patient Sequence No: 1, Text Type: N, H10


[91198574] Doctor initially reports the syringe created necrotic tissue at the injection site. On (b)(6) 2017 doctor reports anesthetic used: septocaine 1:200,000 - approximately 1/3-1/2 carpule injected at cervical of facial surface of tooth at gum line under pressure at 3 sites mesial proximal, facial, distal proximal. Chlorhexidine rinse cleared up the area. Area resolved without further incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2017-00120
MDR Report Key6975447
Date Received2017-10-25
Date of Report2017-10-05
Date of Event2017-08-28
Date Mfgr Received2017-10-05
Date Added to Maude2017-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameN-TRALIG INTRLGMNTRY SYRG
Generic NameM51 - GENERAL DENTISTRY
Product CodeEJI
Date Received2017-10-25
Catalog Number76-55
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-25

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