NEO-PLX RB TRAY 58067 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-01-15 for NEO-PLX RB TRAY 58067 * manufactured by Heraeus Kulzer, Inc..

Event Text Entries

[19954878] During her treatment on 9/21/98, the dr used neo-plex for an impression. Pt experienced shortness of breath, heart palpatations and wheezing. She said it felt like someone was sitting on her chest. She said the dr administered nitrous oxide and then oxygen. Her symptoms continued, so pt insisted that an ambulance be called. The emergency medical technician administered nitroglycerin and baby aspirin. Pt was taken to hosp and was treated by an emergency room physician. According to pt, the dr administered a "large" dose of benadryl. Her symptoms subsided and she was released and 4 1/2 hrs in er - no further treatment was indicated. Dr had given her the material safety data sheet for neo-plex. Her call today was to discuss the material safety data sheet and the potential "hazardous" materials in the product. Co explained "ios" standards, research and development of products and the long time use and history of neo-plex. She said she knows that dr uses it because it is "cheap" and the majority of the pts in the practice are "med-cal". She indicated that she was not aware of any allergy to the material before it was used and has had several impressions taken with alginate and other materials. She said she has a severe gag reflex and during the procedure, she didn't want the dr to apply a topical anesthetic because she has "drown" with excess water and fluids on previous occasions. She said that today her whole body is "shutting down". She has developed a cough, sinusitis and a yeast infecion. She has scheduled an appointment with her allergist for 9/24/98 and will be seeing her gynecologist in the near future. She said she is allergic to bee stings (she carries an allergic reaction kit with her including benadryl), penicillin and motrin. She also avoids sulfa as her father almost died after being treated with sulfa drugs. She is also allergic to latex balloons - her mouth breaks out. However, she did say that she uses latex condoms for birth control and does not have a reaction to that latex. She indicated that when she sees the allergist, they will do a skin test - they had been thinking about doing a skin test for a while, but now she will insist. She said she thinks she is allergic to pine trees. Co encouraged her to see a physician. Discussed that co will be happy to provide the allergist with add'l info if needed. She added that her father-in-law is a dentist. Pt has co's phone number and technical svc's extension. Co is not aware of what other products may have been used during her treatment. Co is also not aware that the reaction was caused specifically by the neo-plex. Co phoned dr's office to inform him that the pt had contacted co - he was not in. Co did leave a message with the receptionist including co's name and number if he would like to call. 9/28/98 tech svc follow up call to dr's office: dr was at lunch. Co asked to please have the dr call. She has not heard from pt since the incident. Dr will call - asks to be updated after conversation with the dr. 9-28-98 dr was with a pt - took another message to please have dr call. Dr called co back: he said pt is now fine. He used neo-plex in a custom tray (methylmethacrylate) and latex gloves only during the procedure. He is not sure what caused the reaction. He has used neo-plex for years and never had a problem. Discussed sulfur base as pt had indicated that she avoids sulfa. Again, he said he is not really sure what caused the reaction. He indicated that pt had left the building after her appointment and returned complaining of chest pain which he felt was unusual for an individual 38 years old. He administered oxygen and nitrous thinking that it might have been an asthma attack. When the symptoms continued, they called 911. He again said that pt is fine. Co invited dr to call if co could be of further assistance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-1998-00001
MDR Report Key207619
Report Source04
Date Received1999-01-15
Date of Report1998-11-30
Date of Event1998-09-21
Date Mfgr Received1998-09-23
Date Added to Maude1999-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEO-PLX RB TRAY
Generic NameIMPRESSION MATERIAL
Product CodeEBH
Date Received1999-01-15
Model Number58067
Catalog Number*
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key201518
ManufacturerHERAEUS KULZER, INC.
Manufacturer Address4315 S. LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Baseline Brand NameNEO-PLX RB TRAY
Baseline Generic NameIMPRESSION MATERIAL
Baseline Model No58067
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-01-15

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