MAUDE MDR 6003049

MDR report key
6003049
Report number
MW5065228
Event key
0
Event type
3
Date of event
2016-10-01
Date received
2016-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
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
1UNSCENTED BABY WIPESBABY WIPESUNKLRJL16212* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-050

Event Narratives#

D

Patient 1

I PURCHASED A BOX OF (B)(6) ELEMENTS BABY WIPES WHICH I USE FOR DIAPER CHANGING, WIPING MY SON'S HANDS AND FACE, AND OTHER SURFACES HE MIGHT TOUCH. ON SATURDAY MORNING OF (B)(6), I PULLED A FRESH WIPE OUT OF A PACKAGE I WAS CURRENTLY USING AND SAW WHAT APPEARED TO BE BLOOD AND HAIR ON THE PRODUCT. I HAD USED ALMOST ALL THE PREVIOUS WIPES IN THIS PACKAGE THAT DID NOT APPEAR TO BE STAINED OR HAVE HAIR EMBEDDED, THE CONTAMINATED WIPE WAS ONE OF THE LAST FEW AND I SAW THE CONTAMINATION AND DID NOT USE IT ON MY SON. I AM VERY CONFIDENT THAT NO ONE IN MY HOUSEHOLD HAD CONTAMINATED THIS WIPE. I AM VERY CONCERNED ABOUT THIS UNK AND POTENTIALLY BIO HAZARDOUS MATERIAL THAT COULD HAVE COME INTO CONTACT WITH MY BABY. I CONTACTED (B)(6) ABOUT THIS INCIDENT AND RECEIVED A REPLY THROUGH EMAIL. I AM ABLE TO SEND PHOTOS AND THE CONTAMINATED PRODUCT AT YOUR REQUEST. I WILL INCLUDE MORE INFO ON THE PACKAGING OF THE PRODUCT HERE: L16212 17:33 LINE#72N (B)(6) ELEMENTS UNSCENTED BABY WIPES 80 COUNT PACKAGE.