MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-09 for CONFORM (TM) EXTENDED ANATOMICAL CHIN CEAC-L manufactured by Implantech Associates, Inc..
[5280655]
Complainant reported that patient complained of bad taste in mouth approximately 7 months post-implantation with chin implant. Subsequently, patient complained of pain and discomfort, as well. No biopsy or culture was ever taken, and patient was prescribed two courses of amoxicillin (po) and peridex oral rinse. Device was explanted due to infection approximately one year post-operatively.
Patient Sequence No: 1, Text Type: D, B5
[12875681]
Patient: infection, pain. Device: no known device problem. Method: reviewed device history records, sterilization records, environmental monitoring records, and product labeling. Results: device history records review found no assignable cause for the reported events. The sterilization process was within specified parameters, and there have been no other infection-related complaint reports associated with this sterile lot of (b)(4) devices. Product labeling addressed the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2015-00002 |
| MDR Report Key | 4410118 |
| Report Source | 05 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-12-10 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-01-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORM (TM) EXTENDED ANATOMICAL CHIN |
| Generic Name | CHIN IMPLANT |
| Product Code | FWP |
| Date Received | 2015-01-09 |
| Model Number | NA |
| Catalog Number | CEAC-L |
| Lot Number | 851364 |
| ID Number | NA |
| Device Expiration Date | 2018-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-09 |