MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-20 for CONFORM TERINO MALAR SHELL IMPLANT, SMALL CTMS-S4 manufactured by Implantech Associates Inc..
[21047550]
The complainant physician reported that pt was implanted with malar implants and subsequently had devices explanted bilaterally due to infection. Prior to explant, both sides were drained on several occasions. No culture was taken, so no organism has been identified.
Patient Sequence No: 1, Text Type: D, B5
[21210684]
Method: reviewed device history records, sterilization records, and product labeling. Device history record review revealed no assignable cause for the reported event. Product labeling addresses the possibility of infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00007 |
| MDR Report Key | 2890543 |
| Report Source | 05 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-12-20 |
| Date of Event | 2012-11-26 |
| Date Mfgr Received | 2012-11-26 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-01-02 |
| 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 |
| 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 TERINO MALAR SHELL IMPLANT, SMALL |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2012-12-20 |
| Model Number | NA |
| Catalog Number | CTMS-S4 |
| Lot Number | 845065 |
| ID Number | NA |
| Device Expiration Date | 2017-05-01 |
| 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 | 2012-12-20 |