MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-08 for CONTOURFLEX (TM) TEARDROP GLUTEAL IMPLANT N/A CCB6-1 manufactured by Implantech Associates, Inc..
[66815720]
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed manufacturing records, sterilization records, and product labeling. Results: no failure was detected. Conclusion: the possibility of serous fluid accumulation and/or infection are known, inherent risks associated with implant surgery.
Patient Sequence No: 1, Text Type: N, H10
[66815721]
Complainant reported that patient who had implantech gluteal implants placed in the calf region bilaterally, subsequently developed serous fluid accumulation in the area of the right side implant. Patient had the area drained repeatedly starting approximately 2 months post-operatively. For the next 21 months, the patient had the area drained repeatedly and took several courses of oral antibiotics, as well. The patient had the right side device explanted approximately 23 months post-operatively. Complainant reported that cultures taken 3 weeks before explant and on the day of the explant came back negative. There was a culture taken from the patient about 8 days after the explant surgery, and psuedomonas aeruginosa was identified. In latest follow up with complainant, patient's infection appears to be resolved, however patient has not scheduled any replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2017-00002 |
| MDR Report Key | 6311439 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2017-01-11 |
| Device Manufacturer Date | 2013-06-26 |
| Date Added to Maude | 2017-02-08 |
| 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) TEARDROP GLUTEAL IMPLANT |
| Generic Name | GLUTEAL IMPLANT |
| Product Code | MIB |
| Date Received | 2017-02-08 |
| Model Number | N/A |
| Catalog Number | CCB6-1 |
| Lot Number | 850515 |
| Device Expiration Date | 2018-06-01 |
| Operator | PHYSICIAN |
| 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 | 2017-02-08 |