Catalog Number 65872354 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Local Reaction (2035); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Caustic/Chemical Burns (2549)
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Event Date 04/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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This material is known to be caustic to soft tissue.Our dfu states "to protect mucous membranes by using a rubber dam.Make sure that gluma desensitizer only comes into contact with the area to be treated.Make sure that only the smallest possible amount required is applied and that it only comes into contact with the area to be treated.It is a local irritant and has toxic effects.Appropriate precautions should always be taken before using gluma desensitizer".Per the patient, there was no rubber dam used prior to the initial application of this product.Follow up calls to patient determined that the healing process is still ongoing and she is under treatment with pcp.Kulzer (b)(4) has evaluated based on the given information of the patient that the device has caused the injuries due to a wrong application procedure and a lack of protection measures.Kulzer (b)(4) reports this incident out of caution to be compliant with 21 cfr 803 and out of abundance of caution.
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Event Description
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Patient was seen in office for anterior veneers.After the prep, gluma was placed by the dental assistant prior to having the temporary crowns placed.Pt immediately began feeling a burning sensation and notified the dental assistant.There was no rubber dam or barrier protection placed prior to the gluma desensitizer.Patient was told to spit out the product and was given water to rinse out with.The dr then returned to the room and "painted on" the gluma and seated the temporaries.Patient was seen at the er the day after with complaints of a burning sensation and irritation on her lips and gums.Patient was also seen by her primary medical dr for the same concerns.Patient was prescribed ibuprofen, prednisone and some mouthwash ((b)(6) mouthwash).
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Manufacturer Narrative
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This material is known to be caustic to soft tissue.Our dfu states "to protect mucous membranes by using a rubber dam.Make sure that gluma desensitizer only comes into contact with the area to be treated.Make sure that only the smallest possible amount required is applied and that it only comes into contact with the area to be treated.It is a local irritant and has toxic effects.Appropriate precautions should always be taken before using gluma desensitizer".Per the patient, there was no rubber dam used prior to the inital application of this product.Follow up calls to patient determined that the healing process is still ongoing and she is under treatment with pcp.Kulzer gmbh has evaluated based on the given information of the patient that the device has caused the injuries due to a wrong application procedure and a lack of protection messures.Kulzer gmbh reports this incident out of caution to be compliant with 21 cfr 803 and out of abundance of caution.After further consideration we inadvertently checked box h7 "notification" which was a mistake in understanding the intention of h7 (if remedial action initiated) on our part and should not have been selected.Kulzer initiated no remedial action due to this event.
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Event Description
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Patient was seen in office for anterior veneers.After the prep, gluma was placed by the dental assistant prior to having the temporary crowns placed.Pt immediately began feeling a burning sensation and notified the dental assistant.There was no rubber dam or barrier protection placed prior to the gluma desentisizer.Patient was told to spit out the product and was given water to rinse out with.The dr then returned to the room and "painted on" the gluma and seated the temporaries.Patient was seen at the er the day after with complaints of a burning sensation and irritation on her lips and gums.Patient was also seen by her primary medical dr for the same concerns.Patient was prescribed ibuprofin, prednisone and some mouthwash (mary's magic mouthwash).(physican's report will be attached).
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Search Alerts/Recalls
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