FDA.reportPublic FDA data

MAUDE MDR 8206655

MDR report key
8206655
Report number
2028924-2018-00011
Event key
0
Event type
3
Date of event
2018-12-19
Date received
2018-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. CRAIG ARTHUR
Address
6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US
Phone
805-805-8053
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CONTOURFLEX(TM) GLUTEAL IMPLANT ROUNDCONTOURED CARVING BLOCKIMPLANTECH ASSOCIATES, INC.MIBN/ACCB5-NC-3876387R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-3101. R

Event Narratives#

N

Patient 1

METHOD: AN ANALYSIS OF PRODUCTION RECORDS WAS PERFORMED, AS DEVICE WAS NOT RETURNED. RESULTS: NO PROBLEM WITH THE DEVICE HAS BEEN FOUND. CONCLUSION: THE EVENT IS A KNOWN INHERENT RISK OF THE DEVICE, AND IS AN ADVERSE EVENT ASSOCIATED WITH THE PROCEDURE. NO PROBLEM WITH THE DEVICE HAS BEEN DETECTED.

D

Patient 1

COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF MAJOR PAIN, POSSIBLY DUE TO SHIFTING OF THE IMPLANTS. DEVICES WERE EXPLANTED AND REPLACED BILATERALLY APPROXIMATELY 8 MONTHS POST-OPERATIVELY. (THIS REPORT IS FOR THE LEFT SIDE DEVICE. REFER TO 2028924-2018-00010 FOR REPORT ON THE RIGHT SIDE DEVICE INVOLVING THE SAME PATIENT AND SAME EVENT.)