FDA.reportPublic FDA data

MAUDE MDR 1899177

MDR report key
1899177
Report number
1419937-2010-00037
Event key
0
Event type
3
Date of event
2010-09-30
Date received
2010-10-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1101 CORPORATE DR. MCHENRY IL 60050 US
Phone
800-800-8004
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYDROGEL PADSNURSING PAD, HYDROGELMEDELA, INCNTCUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-2901. O

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED THAT, WHEN USING THE LANOLIN CREAM, SHE FELT BURNING AND PAIN AS SOON AS THE BABY LATCHES ON. SHE SAID IT DOES GO AWAY, BUT IT IS PAINFUL.

N

Patient 1

IN ADDITIONAL FOLLOW-UP, THE CUSTOMER STATED SHE WAS USING THE LANOLIN CREAM IN CONJUNCTION WITH BREASTFEEDING. HOWEVER, THE CREAM CAUSED A BURNING SENSATION WHICH CREATED PAIN WHEN THE BABY LATCHED ON. SHE STOPPED USING THE CREAM, STOPPED BREAST FEEDING, AND TURNED TO PUMPING EXCLUSIVELY (WITH A NON-MEDELA PUMP). THE MANUFACTURER REPRESENTATIVE WHO TOOK THE ORIGINAL CALL SENT THE CUSTOMER HYDROGEL PADS TO HELP WITH THE PAIN. ACCORDING TO THE CUSTOMER, THE PADS CREATED A SMALL, WHITE PUS-FILLED BOIL ON HER NIPPLE (SHE DESCRIBED IT AS BEING LIKE A WHITE HEAD AND A "LITTLE WHITE MARK"), WHICH WAS PAINFUL. SHE STOPPED USING THE HYDROGEL PADS AND CONSULTED A PHYSICIAN, WHO PRESCRIBED AN ANTIBIOTIC (KEFLEX, TAKEN ORALLY 4X A DAY FOR 7 DAYS) OVER THE PHONE, BASED ON HER SYMPTOMS, THINKING THERE COULD BE AN INFECTION. SHE HAS FINISHED THE ANTIBIOTIC AND CURRENTLY HAS NO ISSUES. SHE IS STILL PUMPING EXCLUSIVELY. THE ORIGINAL PRODUCTS WERE NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE.