MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-18 for CONFORM TERINO MALAR SHELL-MEDIUM CTMS-M4 manufactured by Implantech Associates, Inc..
[2768953]
Physician reported that pt experienced left cheek swelling/soft tissue swelling approx 3 weeks post-surgery and was placed on biaxin. Left side was explanted approx 11 weeks post-surgery due to infection. No culture was taken to identify any organism involved. Soft tissue swelling and edema lessened over the next several weeks. The left cheek implant was replaced on (b)(6) 2012, and there was no excessive swelling and tenderness only lasted 3 day post-surgery. Pt is doing very well.
Patient Sequence No: 1, Text Type: D, B5
[10062453]
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 this sterile lot. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00004 |
| MDR Report Key | 2624126 |
| Report Source | 05 |
| Date Received | 2012-06-18 |
| Date of Report | 2012-06-08 |
| Date of Event | 2011-10-06 |
| Date Mfgr Received | 2012-04-21 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2012-06-22 |
| 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-MEDIUM |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2012-06-18 |
| Model Number | NA |
| Catalog Number | CTMS-M4 |
| Lot Number | 840033 |
| ID Number | NA |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-06-18 |