FDA.reportPublic FDA data

MAUDE MDR 5150187

MDR report key
5150187
Report number
3006774448-2015-00002
Event key
0
Event type
3
Date of event
2015-09-11
Date received
2015-10-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JOHN GHERMAN
Address
6005 HIDDEN VALLEY RD SUITE 230 CARLSBAD CA 92011 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYGEIA FLANGEFLANGEHYGEIA II MEDICAL GROUP INC.HGYNANANAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-0701. O

Event Narratives#

N

Patient 1

THE CUSTOMER SERVICE REPRESENTATIVE TROUBLESHOOTED WITH THE CUSTOMER AT THE DATE OF THE EVENT AND FOUND THAT THE PUMP SOUNDED FINE, AND THE PIECE OF PLASTIC ON THE FLANGE ASSEMBLY LOCATED INSIDE THE FLANGE ASSEMBLY JUST ABOVE THE PART WHERE THE TUBING IS ATTACHED HAD A PIECE OF PLASTIC STICKING OUT. THE CUSTOMER SERVICE REPRESENTATIVE SENT COMPLIMENTARY FLANGES TO THE CUSTOMER. THE CUSTOMER WAS ALSO REFERRED TO GO SEE A LOCATION CONSULTANT TO HAVE THE FLANGE SIZE CHECKED. ON (B)(6) 2015, THE CUSTOMER SERVICE REPRESENTATIVE CONTACTED THE CUSTOMER TO FOLLOW-UP WITH THE FLANGES THAT THE CUSTOMER SERVICE REPRESENTATIVE HAD SENT THE CUSTOMER. THE CUSTOMER WAS HAPPY ABOUT THE FLANGES THAT THE CUSTOMER SERVICE REPRESENTATIVE HAD SENT THE CUSTOMER, AND THE CUSTOMER STATED THAT THE CUSTOMER DID NOT HAVE ANY ISSUES OR CONCERNS.

D

Patient 1

CUSTOMER CONTACTED OUR CUSTOMER SERVICE REPRESENTATIVE ON (B)(6) 2015 STATING THAT THERE WAS A NICK IN THE PLASTIC ON THE INSIDE OF ONE OF THE FLANGES. THE FLANGE GOT CAUGHT ON THE CUSTOMERS SKIN, CAUSING THE CUSTOMER TO BLEED. THE CUSTOMER STATED THAT THE CUSTOMER FELT A ROUGH SPOT ON THE FLANGE A COUPLE DAYS PRIOR TO THE DATE OF THE EVENT.