MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2017-08-23 for FLOWERS EXTENDED TEAR TROUGH (R) IMPLANT N/A EFTT-L manufactured by Implantech Associates, Inc..
[83468596]
Evaluation summary: method: the actual device was not evaluated, however implantech reviewed sterilization records, manufacturing records, and product labeling. Results: no failure was detected. Conclusion: the possibility of abscess and infections is a known, inherent risk associated with implant surgery.
Patient Sequence No: 1, Text Type: N, H10
[83468597]
Patient reported developing abscess and infection in sinus after receiving implantech tear trough implant and suprafoil implant which she received to treat area affected by trauma. (note: the suprafoil implant, manufactured by f. Jackson, inc in (b)(4), is not known by implatech to be commonly used in conjunction with our implants. ) patient had surgery to drain and scrape the affected area approximately 3 months post-operatively. Patient has received multiple courses of antibiotics (cipro p. O. ). Patient and current treating physicians have verified that symptoms associated with infection have resolved and antibiotics have been discontinued. (note: implanting physician has been listed as the reporter, however patient received latest follow-up from another physician. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2017-00004 |
| MDR Report Key | 6813367 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2017-01-16 |
| Date Added to Maude | 2017-08-23 |
| 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 | 3 |
| Manufacturer Contact | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| 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 | FLOWERS EXTENDED TEAR TROUGH (R) IMPLANT |
| Generic Name | MIDFACIAL IMPLANT |
| Product Code | LZK |
| Date Received | 2017-08-23 |
| Model Number | N/A |
| Catalog Number | EFTT-L |
| Lot Number | 869534 |
| 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 | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-23 |