MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-05-23 for CONFORM EXTENDED ANATOMICAL CHIN CEAC-M manufactured by Implantech Associateds, Inc..
[2004439]
Pt reported having skin reactions approximately 4-5 months after implantation of a chin implant and reconstruction of the nose using cadaveric tissue. At first the red burning areas were lasting about 48 hours showing up on forehead, nose and cheeks. Now it is constant. Pt is concerned about possible allergic reaction to the implant. Pt really likes her chin implant and has not yet decided whether to remove the implant. Follow up with the pt's physician indicates that pt reported rash on face and neck approximately 8 days after implantation, and benadryl was recommended. Subsequently, the pt has been treated with medrol dose packs, xanax, cipro, and mupirocin ointment. The problems have been ongoing, and the pt is seeing a dermatologist. Though the cadaveric tissue reconstruction is one possible source of the reported problem, the doctor cannot rule out the chin implant as a potential cause.
Patient Sequence No: 1, Text Type: D, B5
[9020826]
Method: reviewed device history records, sterilization records, and product labeling. Results: device history records review revealed no assignable cause for the reported event. The sterilization records were within normal parameters and there have been no other reported complaints on this product lot. Product labeling addresses the possibility of complication associated with surgical procedures of this kind, including pt intolerance to any foreign implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2011-00002 |
| MDR Report Key | 2112264 |
| Report Source | 04 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-05-23 |
| Date of Event | 2010-06-30 |
| Date Mfgr Received | 2011-05-02 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-06-09 |
| 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 | STEVE MEADE |
| Manufacturer Street | 6025 NICOLLE ST STE B |
| 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 EXTENDED ANATOMICAL CHIN |
| Generic Name | CHIN IMPLANT |
| Product Code | LZK |
| Date Received | 2011-05-23 |
| Model Number | NA |
| Catalog Number | CEAC-M |
| Lot Number | 834440 |
| ID Number | NA |
| Device Expiration Date | 2015-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATEDS, INC. |
| Manufacturer Address | VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-23 |