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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PATTERSON DENTAL SUPPLY, INC. PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY; SEALANT, PIT AND FISSURE, AND CONDITIONER.

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PATTERSON DENTAL SUPPLY, INC. PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY; SEALANT, PIT AND FISSURE, AND CONDITIONER. Back to Search Results
Catalog Number 089-3990
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction to Medicinal Component of Device (4574)
Event Date 02/18/2022
Event Type  Injury  
Event Description
On (b)(6) 2022 at 4:50pm patient presented for sealants with mom.Patient was anxious during the procedure, sealants on patient face.We rinse her face and dismissed the patient without completing the procedure.On monday, mother reported to our clinic that she was ok on friday but on saturday morning she has reaction.She was admitted into the hospital.She was dismissed on friday.She had skin reaction saturday morning.Recently talked to father, she is okay now and started going to school.Fda safety report id # (b)(4).
 
Event Description
Additional information received from reporter on november 6, 2022 for reporter number mw5108152: investigation results: determined to be an allergic reaction, not a defect related to the product.Investigation not required.Skin sensitization is a known and expected side effect if the material is used outside of its indication (on the tooth).As a precaution, this was reported.
 
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Brand Name
PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY
Type of Device
SEALANT, PIT AND FISSURE, AND CONDITIONER.
Manufacturer (Section D)
PATTERSON DENTAL SUPPLY, INC.
MDR Report Key13770468
MDR Text Key287401098
Report NumberMW5108152
Device Sequence Number1
Product Code EBC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 12/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number089-3990
Device Lot Number210301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/14/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/06/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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