GUTTAFUSION PINK OBTURATOR V041532000025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for GUTTAFUSION PINK OBTURATOR V041532000025 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[60423929] While it is unknown if the guttafusion obturator caused or contributed to the patient's symptoms, it cannot be definitively ruled out. Therefore, this event is reportable per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[60423930] In this event it was reported that a patient experienced swelling and pain all over the face after a root canal treatment where several different products, including a guttafusion obturator, was used. The patient saw a physician and was treated with antibiotics and analgesics. According to the dentist there was no overfilling and sealing was performed. The patient has no history of allergy is doing well now.
Patient Sequence No: 1, Text Type: D, B5


[60450328] Charger and file clip not received. Apex locator checked with test box (b)(4) without errors.
Patient Sequence No: 1, Text Type: N, H10


[65287087] Customer returned one unopened sleeve ((b)(4) pcs) of size r25, lot 0000122780, which is indicated as the lot matching this complaint. Customer also returned 2 additional packs containing size r40, lot 0000105559 and size r50, lot 0000092885. None of the obturators had been opened. No loose or opened obturators were returned. Visually checked obturators and found no fault with the obturators returned. Follow-up #1 was submitted in error and does not pertain to this mfr report number.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9611053-2016-00057
MDR Report Key5501625
Date Received2016-03-15
Date of Report2017-01-19
Date of Event2016-10-13
Date Mfgr Received2017-01-04
Date Added to Maude2016-03-15
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 ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer Street608 ROLLING HILLS DRIVE
Manufacturer CityJOHNSON CITY TN 37604
Manufacturer CountryUS
Manufacturer Postal Code37604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUTTAFUSION PINK OBTURATOR
Generic NameGUTTA-PERCHA
Product CodeEKM
Date Received2016-03-15
Model NumberNA
Catalog NumberV041532000025
Lot Number158540
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-03-15

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