MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-01 for FLOWERS TEAR TROUGH IMPLANT, SMALL FTT-S manufactured by Implantech Associates Inc..
[2853704]
Complainant reported that devices were explanted 18 days post-surgery because complainant felt devices had shifted. After removal of the devices, pt developed nodules on her eyelids. Complainant did not think the devices were related to the eyelid issue. Pt had history of eczema of eyelids. Pt is seeing an ophthalmologist.
Patient Sequence No: 1, Text Type: D, B5
[10087669]
Method: reviewed device history records, including sterilization records, and product labeling. Results: device history record review revealed no assignable cause for the reported event. The sterilization process was within specified parameters, and product labeling addresses the possibility of displacement or shifting of the implants.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2012-00005 |
| MDR Report Key | 2684918 |
| Report Source | 05 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-05-18 |
| Date Mfgr Received | 2012-07-09 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2012-08-08 |
| 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 | FLOWERS TEAR TROUGH IMPLANT, SMALL |
| Generic Name | SILICONE MIDFACIAL IMPLANT |
| Product Code | LZK |
| Date Received | 2012-08-01 |
| Model Number | NA |
| Catalog Number | FTT-S |
| Lot Number | 742517 |
| ID Number | NA |
| Device Expiration Date | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-08-01 |