FDA.reportPublic FDA data

MAUDE MDR 8483902

MDR report key
8483902
Report number
8041101-2019-00036
Event key
0
Event type
3
Date received
2019-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
LINDA PLEWS
Address
199 GRANDVIEW RD SKILLMAN NJ 08558 US
Phone
215-215-2152
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REACH DENTOTAPE 100M EU 87159035 DTAWA45686EUADENTAL FLOSSJOHNSON & JOHNSON CONSUMER INCJES3813700922161038DR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0401. R

Event Narratives#

N

Patient 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER, AGE AT TIME OF EVENT, SEX, WEIGHT AND ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (REACH DENTOTAPE 100M EU 87159035 DTAWA45686EUA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (REACH J&J FLOSS DENTOTAPE 100YD USA (B)(4)). UDI #: (B)(4), UPC = (B)(4), EXPIRATION DATE= NA, LOT NUMBER = 1038D. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (REACH J& J FLOSS DENTOTAPE 100YD USA (B)(4)). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

A CONSUMER REPORTED THAT REACH DENTOTAPE WAS USED AND THE THREAD DIVIDED AND GOT STUCK BETWEEN THE TEETH. THE CONSUMER STATED THAT THE CONSUMER HAD RECEIVED A REPAIRING/FILLING IN THE TOOTH AND A HALF TOOTH DISAPPEARED AFTER DEVICE USE. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.