FDA Adverse Event Injury Summary report: N

ATRISORB-D FREEFLOW BIOABSORBABLE GTR

MDR report key: 2227580 · Received March 11, 2009

Report

Report Number
1724031-2009-00047
Event Type
Injury
Date Received
March 11, 2009
Date of Event
February 1, 2009
Report Date
March 11, 2009
Manufacturer
TOLMAR INC.
Product Code
LYC
PMA / PMN Number
K994137
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MS, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

INITIAL REPORT (B)(6) 2009: THIS DENTIST REPORTS THAT A (B)(6) FEMALE PT STARTED ATRISORB-D, AN UNK DOSE OF 4% STRENGTH, ONCE, ON AN UNK DATE FOR DENTAL SURGERY. THE PT'S MEDICAL HISTORY INCLUDES SINUSITIS, NO HISTORY OF SENSITIVITY TO DOXYCYCLINE, AND A HISTORY OF GASTRIC REFLUX. THE PT'S RELEVANT PAST DRUG HISTORY INCLUDES LEVAQUIN TO TREAT SINUSITIS. THE PT'S CONCOMITANT MEDICATIONS INCLUDE PERIDEX AND SALINE ORAL RINSES AS PART OF POST OPERATIVE CARE. ON AN UNK DATE, THE PT HAD DENTAL IMPLANTS PLACED AND WAS EXPERIENCING SENSITIVITY. ON AN UNK DATE, THE PT HAD DEBRIDEMENT DONE AND FREEZE DRIED BONE AND THE ATRISORB-D WAS PLACED. ONE WEEK LATER, ON AN UNK DATE, SHE DEVELOPED BLISTERS ON THE BUCCAL MUCOSA AND PART OF THE GRAFT HAD SLOUGHED. ON (B)(6) 2009, SHE HAD A BLISTER IN THE PALATAL REGION OF HER MOUTH AND IT ALMOST HAD THE APPEARANCE OF ERYTHEMA MULTIFORME. AS OF (B)(6) 2009, IT IS UNK IF THE PT CONTINUES TREATMENT WITH THE ATRISORB-D AND SHE STILL HAS BLISTER IN THE PALATAL REGION OF HER MOUTH. FOLLOW-UP REPORT (B)(6) 2009: THIS DENTIST REPORTS THAT THE PT HAD STARTED THE ATRISORB-D FREE FLOW BARRIER WITH 4% DOXYCYCLINE TWO WEEKS AGO IN (B)(6) 2009. THE TERM "ERYTHEMA MULTIFORM" WAS JUST A DESCRIPTIVE TERM HE USED TO DESCRIBED THE APPEARANCE OF THE BLISTERS THAT THE PT HAD DEVELOPED. THE DENTIST REPORTS THAT THE PT DOES NOT HAVE ERYTHEMA MULTIFORM AND THE BLISTERS ACTUALLY LOOK MORE LIKE CANDIDIASIS. IN 2009, AT AN UNK TIME AFTER STARING THE ATRISORB-D, SHE WAS DIAGNOSED WITH CANDIDIASIS, FOR WHICH SHE STARTED TAKING NYSTATIN. THE PT WAS DOING BETTER UNTIL YESTERDAY, ON (B)(6) 2009, WHEN A NEW GROUP OF BLISTERS BROKE OUT IN HER MOUTH. THIS DENTIST STATED THAT HE DOES NOT SUSPECT THAT THE ATRISORB-D CAUSED THE BLISTERS, BUT INSTEAD HE THINKS LEVAQUIN IS THE CAUSE. AS OF (B)(6) 2009, THIS DENTIST HAS NO PLANS TO REMOVE THE ATRISORB-D AT THIS TIME, AND THE PT CONTINUES TAKING LEVAQUIN AND NYSTATIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ATRISORB-D FREEFLOW BIOABSORBABLE GTR LYC TOLMAR INC. 2903

Patients

Seq Age Sex Outcome Treatment
1 55 YR Other SALINE ORAL RINSE| NYSTATIN| PERIDEX