MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-27 for CONTOURFLEX(TM) GLUTEAL IMPLANT ROUND N/A CCB5-2 manufactured by Implantech Associates, Inc..
[128471492]
Method: the actual device was not returned, and implantech reviewed production/manufacturing records, including labeling review. Results: no problem with the device was identified. Conclusions: implantech has concluded the event is a known, inherent risk associated with implant procedures. No problem with the device has been identified.
Patient Sequence No: 1, Text Type: N, H10
[128471493]
Complainant reported that patient experienced serous fluid accumulation on the right side after bilateral placement with gluteal implants. The physician made multiple attempts to drain the right side, however swelling and serous fluid accumulation persisted. Approximately 9 months post-operatively, the right side device was explanted and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00009 |
| MDR Report Key | 8106766 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-11-27 |
| 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 |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIB |
| Date Received | 2018-11-27 |
| Model Number | N/A |
| Catalog Number | CCB5-2 |
| Lot Number | 874027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-27 |