FDA.reportPublic FDA data

MAUDE MDR 8444303

MDR report key
8444303
Report number
MW5085093
Event key
0
Event type
3
Date of event
2019-03-17
Date received
2019-03-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REACH WAXED UNFLAVORED WAXED FLOSS 55 YDFLOSS, DENTALJOHNSON AND JOHNSON CONSUMER INC.JES26918D* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-210

Event Narratives#

D

Patient 1

OPENED A BOX OF REACH BRAND WAXED, UNFLAVORED DENTAL FLOSS, FROM LOT 26918D, SCAN CODE (B)(4), AND FOUND THE PRODUCT WAS EXCESSIVELY OVER-WAXED, WITH CLUMPS OF WAX ON THE FLOSS. THIS IS VERY INCONSISTENT WITH TYPICAL PRODUCT PURCHASED FOR THIS BRAND AND TYPE. WHEN TRYING TO USE IT, THE EXCESSIVE WAX WOULD FALL OFF AND SHED. PULLING THE STRAND FURTHER TO EXAMINE IF THIS CONSISTENCY WAS THROUGHOUT THE PACKAGE. I DID NOT FIND ANY LESSER-WAX APPLICATION ON THE PRODUCT. ATTEMPTS TO MFR (AND MYSTERY WHO IS THE MFR? SINCE IT MIGHT NOT BE JOHNSON AND JOHNSON ANYMORE) TO INFORM THEM ABOUT THE PROBLEM HAS NOT RESULTED IN BEING ABLE TO NOTIFY ANYONE OF THE ISSUE. THERE IS NO WEBSITE THAT INFORMS CONSUMER HOW TO REACH A CUSTOMER FEEDBACK LOOP FOR PRODUCT: IT SEEMS TO HAVE BEEN PULLED: THERE IS A PROBLEM WITH THE PRODUCT QUALITY; THERE IS A PROBLEM WITH BEING ABLE TO REPORT TO THE MFR, THAT THERE IS A PRODUCT QUALITY. AND IT'S PRETTY UNCLEAR WHO IS THE MFR (NO CLEAR WAY TO IDENTIFY WHO IS MAKING REACH BRANDED PRODUCTS NOW?). DISTRIBUTED BY JOHNSON AND JOHNSON.