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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION TUBLI-SEAL; ROOT CANAL FILLING
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KERR CORPORATION TUBLI-SEAL; ROOT CANAL FILLING Back to Search Results
Catalog Number 00340
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
A complainant alleged that a patient had to undergo surgery due to damage caused to the alveolar nerve and to alleviate pain.The surgeon noted that there was a small piece of sealer found beyond apex of #18.It was also stated that allegedly the sealant had leaked out and damaged the alveolar nerve.The initial doctor that put the tubli-seal sealant stated that the procedure was done three years prior and did not use any other material.No lot number was provided, however review of the ifu/dfu was conducted.Such risks were identified on the ifu/dfu.The product is unavailable for return.
 
Event Description
A complainant alleged that a patient had to undergo surgery due to damaged caused to alveolar nerve.The surgeon also noted there was a small piece of sealer found beyond the apex.It was noted that after the surgery there was no further visual disturbances that can be seen.
 
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Brand Name
TUBLI-SEAL
Type of Device
ROOT CANAL FILLING
Manufacturer (Section D)
KERR CORPORATION
28200 wick rd
romulus MI 48174
MDR Report Key12329023
MDR Text Key266866380
Report Number2024312-2021-00002
Device Sequence Number1
Product Code KIF
Combination Product (y/n)N
PMA/PMN Number
K153067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number00340
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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