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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIX ADHESIVE LIQUID; AGENT, TOOTH BONDING, RESIN
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FIX ADHESIVE LIQUID; AGENT, TOOTH BONDING, RESIN Back to Search Results
Catalog Number 616.01.004
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4).
 
Event Description
It was reported that a patient may have experienced a possible allergic reaction to the use of fix adhesive.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the patient outcome.
 
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Brand Name
FIX ADHESIVE LIQUID
Type of Device
AGENT, TOOTH BONDING, RESIN
MDR Report Key11944690
MDR Text Key254484430
Report Number8010638-2021-00004
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number616.01.004
Device Lot Number2010000903
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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