FDA Adverse Event
Injury
Summary report: N
FEE,MISCELLANEOUS,DIV21
MDR report key: 24547804
·
Received March 9, 2026
Report
- Report Number
- 1417592-2026-00199
- Event Type
- Injury
- Date Received
- March 9, 2026
- Date of Event
- February 9, 2026
- Report Date
- April 28, 2026
- Manufacturer
- MEDLINE INDUSTRIES, LP
- Product Code
- PUI
- Removal / Correction Number
- R-26-003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATE TO H7: IF REMEDIAL ACTION INITIATED, CHECK TYPE. UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE FACILITY IS INVESTIGATING SURGICAL SITE INFECTIONS. IT WAS REPORTED THAT "WE ARE LOOKING INTO ANY AND EVERY POSSIBLE COMMONALITY FOR THESE CASES." NO ADDITIONAL INFORMATION WAS PROVIDED. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE FACILITY IS INVESTIGATING SURGICAL SITE INFECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474733 | FEE,MISCELLANEOUS,DIV21 | PUI | MEDLINE INDUSTRIES, LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |