SILICONE PLASTIC NOSE PIECE-SCAVANGER MASK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-20 for SILICONE PLASTIC NOSE PIECE-SCAVANGER MASK manufactured by Porter Instruments, Inc..

Event Text Entries

[14409] Rptr personally met and reported reaction with dentist within 30 or so mins after exposure to what the employee identified as a hot sterilant solution or solutions rptr believes, from documents and knowledgeable persons comments, were either inappropriately applied, or not adequately outgassed or otherwise removed from silicone nose piece (which style, according to the inventor, was an out-dated old style and should have been thrown away several years ago) through which rptr was induced under a combination of 50% nitrous oxide and 50% oxygen during the dental hygiene treatment on that morning. Immediately, even before dentist turned on the gases, rptr inhaled through the nose piece. Rptr instantly experienced a severe burning in sinuses and eyes. Rptr ripped off the nose piece and exclaimed that "the unit smells of bleach and hurts rptr. " dentist said to rptr that "the nose piece has just come from the sterilizer" and what rptr smelled "was not bleach, but glutaraldehyde in the sterilizing solution in the sterilizer. Rptr sniffed the device at some distance and confirmed that the smell was reminiscent of formalin. Dentist reassured rptr, saying "it (the solution) is safe to use, we use it every day. " she said "i am not sure washing would help, because the chemicals are absorbed into the porous silicone rubber," but she did so for less than one min with soap and water. She told that "thin disposable sterile plastic shields are made for this nose piece, but we don't have any and we don't use them anyway because people find them uncomfortable. " she said that "most people use nothing when having their teeth cleaned, but certain nervous persons were given oxygen to help relax them and that few of their pts wanted nitrous oxide. " soley relying on her statement of safety for the solution, rptr trusted her opinion and accepted her beginning the anesthesia and cleaning to be done. She replaced the nose piece on rptr nose and turned on the anesthetic gasses. Rptr still could strongly smell what he clearly identified as an odor similar to formalin, but masked with soap smell. Rptr continued to have sinus pain and burning eyes, but somewhat lessened. She told me to "close your eyes if they burn; all you smell is the odor from the sterilizer solution. Rptr explained to her that "the odor was in the material of the nosepiece. " she attempted to reduce the buring in rptr's eyes by placing two rolls of dense cotton approx 1/4" x 1 1/2" under the sides of the nose piece beneath his eyes. Dentist had turned on the gasses to what she identified as 50% oxygen and 50% nitrous oxide. Rptr immediately began to feel the analgesic effects of the nitrous oxide. Although his sinuses and eyes continued to pain him, he quickly fell under the effects of the gas. However, well into the cleaning, rptr began to feel a burning in his lungs as well. Finally after fifteen mins or so rptr began to breathe mostly through his n20. (*)
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000764
MDR Report Key26697
Date Received1995-09-20
Date of Report1995-09-14
Date of Event1994-05-04
Date Added to Maude1995-10-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSILICONE PLASTIC NOSE PIECE-SCAVANGER MASK
Product CodeKHA
Date Received1995-09-20
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key27474
ManufacturerPORTER INSTRUMENTS, INC.
Manufacturer AddressHATFIELD PA * US


Patients

Patient NumberTreatmentOutcomeDate
10 1995-09-20

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