MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for CONTOURFLEX (TM) GLUTEAL IMPLANT, ROUND N/A CCB5-4 manufactured by Implantech Associates, Inc..
[103136296]
Method: the actual device was not evaluated, however implantech performed sterilization review, manufacturing review, and labeling evaluation. Results: no failure was detected. Conclusions: infection is a known, inherent risk of implant procedures.
Patient Sequence No: 1, Text Type: N, H10
[103136297]
Complainant reported that patient had gluteal implants explanted bilaterally approximately 17 days post-operatively due to infection. The patient presented with pain, redness, swelling and slight necrosis on the right side 10 days post-operatively and was prescribed a 10 day course of clindamycin po. When issues did not appear to be resolving as fully as desired, the decision was made to explant the devics. A culture was taken, and results found citrobacter braakii. Patient has significant medical history of being pre-diabetic and being (b)(6) since 2002. Physician's office cited poor patient after care as one reason for the event, and initially did not feel devices caused or contributed to the event. Subsequent f/u with complainant indicated that device involvement could not be ruled out, hence implantech has elected to report this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2018-00002 |
| MDR Report Key | 7360090 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2018-03-21 |
| 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 | 0 |
| Brand Name | CONTOURFLEX (TM) GLUTEAL IMPLANT, ROUND |
| Generic Name | CONTOURED CARVING BLOCK |
| Product Code | MIB |
| Date Received | 2018-03-21 |
| Model Number | N/A |
| Catalog Number | CCB5-4 |
| Lot Number | 875177 |
| Operator | PHYSICIAN |
| 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 | 2018-03-21 |