CONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2 N/A CCB6-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-31 for CONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2 N/A CCB6-2 manufactured by Implantech Associates, Inc..

Event Text Entries

[134646363] This report addresses the right side device. This is the same event, same patient that is being reported in report # 2028924-2019-00002 which addresses the left side device.
Patient Sequence No: 1, Text Type: N, H10


[134646364] Complainant reported that patient with gluteal implants had devices explanted bilaterally approximately 7 years and 8 months post-operatively due to pain and migration. Upon explant, the devices were found in several pieces. Complainant confirms devices were carved at the time of implantation. Note: this report addresses the right side device. This is the same event, same patient that is being reported in report # 2028924-2019-00002 which addresses the left side device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028924-2019-00003
MDR Report Key8294315
Report SourceHEALTH PROFESSIONAL
Date Received2019-01-31
Date of Report2019-01-31
Date of Event2019-01-09
Date Mfgr Received2019-01-09
Device Manufacturer Date2011-03-14
Date Added to Maude2019-01-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CRAIG ARTHUR
Manufacturer Street6025 NICOLLE STREET, SUITE B
Manufacturer CityVENTURA CA 93003
Manufacturer CountryUS
Manufacturer Postal93003
Manufacturer Phone8053399415
Manufacturer G1IMPLANTECH ASSOCIATES, INC.
Manufacturer Street6025 NICOLLE STREET, SUITE B
Manufacturer CityVENTURA CA 93003
Manufacturer CountryUS
Manufacturer Postal Code93003
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2
Generic NameCONTOURED CARVING BLOCK IMPLANT
Product CodeMIB
Date Received2019-01-31
Returned To Mfg2019-01-18
Model NumberN/A
Catalog NumberCCB6-2
Lot Number839108
Device Expiration Date2016-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIMPLANTECH ASSOCIATES, INC.
Manufacturer Address6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.