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..
[134647415]
This report addresses the left side device. This is the same event, same patient that is being reported in report # 2028924-2019-00003 which addresses the right side device.
Patient Sequence No: 1, Text Type: N, H10
[134647416]
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 left side device. This is the same event, same patient that is being reported in report # 2028924-2019-00003 which addresses the right side device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2019-00002 |
| MDR Report Key | 8294311 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2011-03-14 |
| Date Added to Maude | 2019-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOURFLEX (TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) SIZE 2 |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIB |
| Date Received | 2019-01-31 |
| Returned To Mfg | 2019-01-18 |
| Model Number | N/A |
| Catalog Number | CCB6-2 |
| Lot Number | 839108 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-31 |