MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-11-17 for CONFORM TERINO MALAR SHELL CTMS-M4 manufactured by Implantech Associates, Inc..
[350020]
Pt developed an infection after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2003-00002 |
| MDR Report Key | 496204 |
| Report Source | 05 |
| Date Received | 2003-11-17 |
| Date of Report | 2003-11-17 |
| Date of Event | 2003-09-26 |
| Date Mfgr Received | 2003-10-29 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2003-11-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN MEADE |
| Manufacturer Street | 2064 EASTMAN AVE #101 |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | * |
| Manufacturer Street | 2064 EAST AVE #101 |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORM TERINO MALAR SHELL |
| Generic Name | SILICONE FACIAL IMPLANT - MALAR |
| Product Code | LZK |
| Date Received | 2003-11-17 |
| Returned To Mfg | 2003-11-06 |
| Model Number | NA |
| Catalog Number | CTMS-M4 |
| Lot Number | 611667 |
| ID Number | NA |
| Device Expiration Date | 2003-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 484937 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 2064 EASTMAN AVE., UNIT 101 VENTURA CA 93003 US |
| Baseline Brand Name | CONFORM TERINO MALAR SHELL |
| Baseline Generic Name | MALAR IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | CTMS-M4 |
| Baseline Device Family | FACIAL IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901662 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-11-17 |