FLEXITIME CORRECT FLOW (DEVICE 2) 50034806

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-01 for FLEXITIME CORRECT FLOW (DEVICE 2) 50034806 manufactured by Heraeus Kulzer, Gmbh.

Event Text Entries

[3713185] This is the second of two reports involving two separate hk medical devices for one event. Dental assistant called and said that they had a pt possibly aspirate some of the flexitime during an invisalign appointment. She said that a very experienced assistant took the maxillary impression. She said that the pt started choke so they removed the impression. She said that it took a few seconds to remove as the material was almost set up. She said that the pt was coughing and complaining that she felt like something was stuck in her throat so they had her continue to keep coughing. She coughed up a little of the impression material but still felt some more was in her throat. She did ask the dentist to take her mandibular impression before leaving for the hospital, but the dentist refused and had (b)(6) drive the pt to the er. (b)(6) said that the pt's cough decreased while driving and no bronchospasms were noted. She said that the er wanted to know if the impression material was radiopaque. Advised that the impression material has a low level radiodensity. She said they had tried x-raying it and saw that also. She said that the hospital has advised that the radiograph they took did not show any material in her airway. She said that the pt is fine now. But they are continuing to monitor her in the hospital. On (b)(6) 2013 spoke to assistant. She said that the pt was released from the hosp last night. She said that she is doing fine today. On (b)(4) 2013 spoke to (b)(6). She said that the putty was placed in the pt's mouth for 5 seconds then removed and the cf was added to the putty and placed back into the mouth for 3 minutes. The pt started gagging then coughing around three minutes and the impression was removed. She said the impression was definitely not overfilled and the pt was sitting straight up with head parallel to the floor. She said that when the pt started gagging she was told to lean her head forward. She said that they have not contacted the pt since early yesterday, so they assume she is still doing fine. On (b)(4) 2013 spoke to assistant. She said the pt is fine. Pt was released from care and they do not believe she aspirated any of the impression material. She said she will contact if any r? Ther treatment is needed. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2013-00098
MDR Report Key3292110
Date Received2013-08-01
Date of Report2013-07-08
Date of Event2013-07-08
Date Facility Aware2013-07-08
Date Added to Maude2013-08-19
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 466142517
Manufacturer CountryUS
Manufacturer Postal466142517
Manufacturer G1HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
Manufacturer Street4315 SOUTH LAFAYETTE BLVD.
Manufacturer CitySOUTH BEND IN 46614251
Manufacturer CountryUS
Manufacturer Postal Code46614 2517
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFLEXITIME CORRECT FLOW (DEVICE 2)
Generic NameELM MATERILA, IMPRESSION
Product CodeELM
Date Received2013-08-01
Returned To Mfg2013-07-12
Catalog Number50034806
Lot Number380428
Device Expiration Date2015-12-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age4 MO
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER, GMBH
Manufacturer AddressDORMAGEN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-08-01

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