FDA.reportPublic FDA data

MAUDE MDR 2680634

MDR report key
2680634
Report number
1419937-2012-00245
Event key
0
Event type
3
Date of event
2012-07-06
Date received
2012-08-01
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#

Contact
DON ALEXANDER
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
1SOFT SHELL FOR INVERTED NIPPLESMEDELA, INC.HFS80210S80210SR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-0101. O

Event Narratives#

D

Patient 1

THE CUSTOMER CONTACTED CUSTOMER SERVICE TO INQUIRE ABOUT WHAT THE SOFT SHELLS ARE MADE OF, AS SHE HAD DEVELOPED AN ALLERGIC REACTION TO THEM. SHE STARTED USING THE SOFT SHELLS ON (B)(6) 2012 AND STOPPED USING THEM ON (B)(6) 2012. SHE BROKE OUT IN HIVES ON HER STOMACH, FACE, AND ARMS ("IT'S EVERYWHERE"). IT STARTED WITH TWO PERFECT CIRCLES ON HER BREASTS THE SIZE OF THE SHELLS. SHE VISITED HER DOCTOR ON (B)(6) 2012 AND WAS GIVEN A STEROID INJECTION AND A PRESCRIPTION FOR ORAL STEROIDS (PREDNISONE 200MG X 10 DAYS) AND A CREAM (NAME UNK).

N

Patient 1

THE CUSTOMER WAS ADVISED THAT THE SOFT SHELLS ARE MADE OF SILICONE. ATTEMPTS TO CONTACT THE CUSTOMER TO GET ADDITIONAL COMPLAINT INFO AND TO GET THE PRODUCT BACK, INCLUDING A FINAL ATTEMPT BY LETTER, WERE UNSUCCESSFUL. THE CUSTOMER APPEARS TO HAVE EXPERIENCED AN ALLERGIC REACTION TO THE SOFT SHELLS. SHOULD ADDITIONAL INFO OR THE PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.