FDA Adverse Event
Injury
Summary report: N
IRRISEPT
MDR report key: 11367204
·
Received February 23, 2021
Report
- Report Number
- 3005706359-2021-00005
- Event Type
- Injury
- Date Received
- February 23, 2021
- Date of Event
- December 23, 2020
- Report Date
- February 23, 2021
- Manufacturer
- IRRIMAX CORPORATION
- Product Code
- FRO
- UDI-DI
- 10842351190002
- PMA / PMN Number
- K20222
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IRRIMAX IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21 CFR § 803. IRRIMAX WILL CONTINUE TO CONTACT REPORTING PHYSICIAN AND OTHER SOURCES AS NECESSARY FOR THE PURPOSE OF OBTAINING ADDITIONAL INFORMATION AND WILL, AS NECESSARY, FILE A FOLLOW-UP REPORT. THE PREVIOUS PARAGRAPH SHALL BE INCLUDED IN ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC INCLUDING INFORMATION OR REPORTS PROVIDED UNDER THE FREEDOM OF INFORMATION ACT.
Description of Event or Problem · 1
LEFT KNEE (INTERNAL DEHISCENCE) OF ARTHROTOMY REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265731 | IRRISEPT | WOUND CLEANSER | FRO | IRRIMAX CORPORATION | ISEPT-450-USA | 10842351190002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |