MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-27 for COMPOSITE BINDER SUBMALAR II FACIAL IMPLANT EPTFE-BSMII-S manufactured by Implantech Associates Inc..
[2227862]
Physician reported that patient presented to an on-call physician with intra-oral drainage and welling on the left side. Oral clyndomycin was prescribed. A culture was taken and (b)(6) was identified. Device was explanted on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[9375974]
Method: reviewed device history records (including 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 the only other report of infection was reported by the same physician and involved the same product lot. (refer to mdr # 2028924-2011-00005). There were total of 72 products in this sterile lot. Product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2011-00004 |
| MDR Report Key | 2321179 |
| Report Source | 05 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-10-27 |
| Date of Event | 2011-09-09 |
| Date Mfgr Received | 2011-09-28 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2011-11-04 |
| 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 | COMPOSITE BINDER SUBMALAR II FACIAL IMPLANT |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2011-10-27 |
| Model Number | NA |
| Catalog Number | EPTFE-BSMII-S |
| Lot Number | 824950 |
| ID Number | NA |
| Device Expiration Date | 2012-09-01 |
| 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 | 2011-10-27 |