FDA Adverse Event
Injury
Summary report: N
INTERNAL NASAL SPLINT - OVAL SEPTAL
MDR report key: 11699273
·
Received April 21, 2021
Report
- Report Number
- 1045254-2021-00186
- Event Type
- Injury
- Date Received
- April 21, 2021
- Date of Event
- February 12, 2021
- Report Date
- April 21, 2021
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- LYA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL IN RESPONSE TO A SURVEY THAT THE PACKAGE OF THE INTERNAL NASAL DEVICE WAS INSPECTED EITHER BEFORE OR DURING THE SURGERY. THE PACKAGING DESCRIBED WAS SOILED. PATIENTS DEVELOPED BACTERIAL INFECTION, SEROMA, NECROSIS, FISTULA, AND HEADACHE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601745 | INTERNAL NASAL SPLINT - OVAL SEPTAL | LYA | MEDTRONIC XOMED INC. | 1523000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |