MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-31 for CONTOURFLEX(TM) GLUTEAL IMPLANT ROUND (NATURAL CONTOUR) N/A CCB5-NC-3 manufactured by Implantech Associates, Inc..
[131731512]
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.
Patient Sequence No: 1, Text Type: N, H10
[131731513]
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 right side device. Refer to 2028924-2018-00011 for report on the left side device involving the same patient and same event. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00010 |
| MDR Report Key | 8206645 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2017-09-20 |
| Date Added to Maude | 2018-12-31 |
| 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 ROUND (NATURAL CONTOUR) |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIB |
| Date Received | 2018-12-31 |
| Model Number | N/A |
| Catalog Number | CCB5-NC-3 |
| Lot Number | 873292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-31 |