MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-10 for BINDER SUBMALAR II FACIAL IMPLANT, MEDIUM BSMII-M manufactured by Implantech Associates, Inc..
[2712690]
Physician reported an infection after implantation with malar implants. Subsequently, device was explanted due to the infection. No culture was taken to identify the organism involved. (implantech has requested add'l info, however no add'l info has been rec'd. The device was distributed to physician in (b)(6) 2012, so event would have occurred in 2012. )
Patient Sequence No: 1, Text Type: D, B5
[9909590]
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 process was within specified parameters, and there have been no other reports of infection involving with this sterile lot. (total of 142 products. ) product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00002 |
| MDR Report Key | 2577887 |
| Report Source | 05 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-10 |
| Date Mfgr Received | 2012-04-10 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2012-05-17 |
| 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. SUITE 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 | BINDER SUBMALAR II FACIAL IMPLANT, MEDIUM |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2012-05-10 |
| Model Number | NA |
| Catalog Number | BSMII-M |
| Lot Number | 842502 |
| ID Number | NA |
| Device Expiration Date | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-05-10 |