MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for CONTOURFLEX(TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) N/A CCB6-3 manufactured by Implantech Associates, Inc..
[109099884]
Evaluation summary: method: the actual device was not evaluated, however manufacturing (assembly & packaging) records were reviewed, sterilization process records were reviewed, labeling was evaluated. Results: no failure was detected. Conclusion: the possibility of infection-like symptoms are known, inherent risks of implant surgery. Labeling also discusses the possibility of explant surgery taking place at any time after implantation.
Patient Sequence No: 1, Text Type: N, H10
[109099885]
Complainant reported that patient who received gluteal implants had to have devices explanted bilaterally nine days post-operatively due to signs of infection and apparent organ failure. Patient started to experience problem fairly soon after implantation. When seen 1 week post-op, patient had secretions, pus and foul odor which led reporting physician to think there was an infection. Culture was taken which ended up having a negative result. Patient continued to get worse and appear to develop organ failure (kidney, etc. ) another culture was taken and again the results were negative. Reporting physician considered the possibility of sepsis, but the results of all the cultures taken failed to support presence of any bacterial infection. After removal, the patient's symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00005 |
| MDR Report Key | 7538909 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-05-11 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-05-23 |
| 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 ST., SUITE B |
| Manufacturer City | VENTURA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE ST., 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 | 0 |
| Brand Name | CONTOURFLEX(TM) GLUTEAL IMPLANT, ANATOMICAL (TEARDROP) |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIB |
| Date Received | 2018-05-23 |
| Model Number | N/A |
| Catalog Number | CCB6-3 |
| Lot Number | 875467 |
| 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 ST., SUITE B VENTURA, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-23 |