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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC CHEMFIL ROCK; CEMENT, DENTAL
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DENTSPLY LLC CHEMFIL ROCK; CEMENT, DENTAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Discoloration (2074); Swelling (2091); Dysphasia (2195)
Event Date 04/15/2020
Event Type  Injury  
Event Description
Patient called to report an adverse event involving her chemfil rock device.Patient stated about a week and a half ago, she saw dr.(b)(6) at (b)(6), and got a chemfil rock device implanted.Patient stated she is now experiencing irritation in mucus membranes of her mouth including her tongue, cheek, gums, and rough of mouth.Patient also stated the material is leeching into her mucus membranes.Patient said her tongue and lips burn, and her lips have turned a slightly darker color.Patient said there are 3 purple spots under her tongue on the side of the device, and her lips are swollen.Patient also stated she is experiencing problems with speech since this device was put in her mouth.Patient is very concerned that this device was used off label or is made of something possibly harmful to her.Patient has attempted to reach out to manufacturer but is waiting for a reply.Patient is very frustrated and unsure how to go about getting it removed and would like answers regarding what exactly this device is made of.
 
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Brand Name
CHEMFIL ROCK
Type of Device
CEMENT, DENTAL
Manufacturer (Section D)
DENTSPLY LLC
MDR Report Key10009291
MDR Text Key189495887
Report NumberMW5094311
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
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