FDA.reportPublic FDA data

MAUDE MDR 3353311

MDR report key
3353311
Report number
1925223-2013-00135
Event key
0
Event type
3
Date of event
2013-08-14
Date received
2013-09-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
4315 SOUTH LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLEXITIME CORRECT FLOWELM MATERIAL, IMPRESSIONHERAEUS KULZER GMBHELM50034806390158 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-1101. O

Event Narratives#

D

Patient 1

PT CALLED ASKING FOR INFO ON THE FLEXITIME CORRECT FLOW. SHE SAID THAT SHE COLLAPSED SOON AFTER ITS USE. ASKED FOR THE DENTIST INFO. SHE SAID SHE WAS GOING TO CALL THE OFFICE AND HAVE THEM CALL US. ON (B)(6) 2013, SPOKE TO RECEPTIONIST. SHE SAID THE PT WAS HAVING NIGHTGUARDS MADE. SHE SAID THAT THE PT HAD ONE OF THE TWO IMPRESSIONS TAKEN AND THEN STEPPED OUT WITH HER HUSBAND TO GET AIR. DISCUSSED THAT PT HAD STATED SHE COLLAPSED. SHE SAID SHE DID NOT SEE THE PT COLLAPSE. SHE SAID THAT SHE CAME BACK IN AND THEY DID THE SECOND IMPRESSION. SHE DID NOT KNOW WHAT HAPPENED. SHE SAID THAT THEY HAVE USED VPS IMPRESSION MATERIAL ON HER BEFORE AND THERE WAS NO PROBLEM THAT TIME. ON (B)(6) 2013, DENTAL ASSISTANT CALLED FROM THE OFFICE. SHE STATED THAT THEY DID A TWO-STEP PUTTY/WASH IMPRESSION ON THE MAXILLARY USING FT PUTTY IN PT'S MOUTH FOR ONE MIN THEN FT CF WAS ADDED FOR 3 MINS IN THE PT'S MOUTH. WHEN THEY REMOVED THE IMPRESSION THE PT WAS LIGHT HEADED, WEAK, THIRSTY AND HAD TROUBLE WALKING. THE PT WAS ASSISTED OUT OF THE OFFICE BY HER HUSBAND AND DID NOT RETURN FOR 15 TO 20 MINS. THE PT WANTED TO DO THE MANDIBULAR IMPRESSION. SINCE THERE WAS NO TROUBLE WHEN THEY USED JUST THE PUTTY THEY DID THE MANDIBULAR IMPRESSION USING ONLY THE PUTTY FOR 3 MINS. THE PT WAS FINE WITH THIS IMPRESSION. THE OFFICE THEN DID A BITE REGISTRATION IMPRESSION USING STAR VPS MATERIAL, FROM A DIFFERENT MFR, THIS WAS IN FOR 1 MIN AND THE PT WAS LIGHT HEADED AGAIN. THE ASSISTANT SAID SHE DID NOT SEE THE PT COLLAPSE NOR DID THE PT REPORT COLLAPSING WHILE OUTSIDE. THE PT'S MED HX SHOWS ALLERGY TO PENICILLIN, CLEANING CHEMICALS, AND SINGLE BOND BONDING AGENT. THE PT HAS HAD ANAPHYLACTIC REACTIONS TO OTHER ALLERGENS AND HAS ANEMIA. THE PT WEARS A DENTAL MASK WHEN SHE COMES TO THE OFFICE AND SOMETIMES BRINGS AN AIR PURIFIER. OFFERED TO SEND SAMPLES AND INGREDIENTS LIST FOR ALLERGY TESTING. ON (B)(6) 2013, SPOKE TO RECEPTIONIST. SHE SAID THAT PT WAS SUPPOSED TO SEE THE ALLERGIST LAST WEEK. SHE SAID THAT SHE WAS SUPPOSED TO CALL THEM WITH INFO. SHE SAID THEY HAVE NOT HEARD FROM HER. SHE SAID THAT ASSISTANT WOULD F/U WITH THE PT AND CALL US BACK. PLEASE REFER TO MFR REPORT # 9681707-2013-00008.