FDA Adverse Event
Injury
Summary report: N
HANSON MEDICAL MALAR IMPLANT
MDR report key: 8745468
·
Received June 28, 2019
Report
- Report Number
- 2031444-2019-00001
- Event Type
- Injury
- Date Received
- June 28, 2019
- Date of Event
- May 24, 2019
- Report Date
- June 28, 2019
- Manufacturer
- HANSON MEDICAL INC
- Product Code
- LZK
- UDI-DI
- B049M430
- PMA / PMN Number
- K973574
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: REVIEWED THE COMPLAINT NOTES, DEVICE HISTORY RECORD, RISK ANALYSIS, AND PRODUCT LABELING. RESULTS: REVIEW OF THE COMPLAINT NOTES AND DEVICE HISTORY RECORD REVEALED NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. EXTRUSION IS A KNOWN RISK. PRODUCT LABELING CAUTIONS: "COMPLICATIONS, ALTHOUGH UNCOMMON, INCLUDE INFECTION, EXTRUSION, IMPLANT MOVEMENT, PAIN, ITCHING, IRRITATION, FLUID ACCUMULATION, BLEEDING, BRUISING, AND CAPSULAR CONTRACTURE."
Description of Event or Problem · 1
PHYSICIAN REPORTED THAT A PATIENT PRESENTED WITH EXTRUSION OF THE LEFT MALAR IMPLANT ON (B)(6) 2019. ORIGINALLY IMPLANTED ON (B)(6) 2019 AFTER WHICH THE PATIENT FELT DISCOMFORT. SUBSEQUENTLY, IMPLANTS WERE REMOVED BILATERAL ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539363 | HANSON MEDICAL MALAR IMPLANT | MALAR IMPLANT | LZK | HANSON MEDICAL INC | M 4 - 3 | 15943 | B049M430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |