FDA Adverse Event
Injury
Summary report: N
CEMENT SIMPLEX ANTIBIOTIC BONE
MDR report key: 17531279
·
Received August 12, 2023
Report
- Report Number
- MW5138194
- Event Type
- Injury
- Date Received
- August 12, 2023
- Date of Event
- September 18, 2020
- Report Date
- February 14, 2022
- Manufacturer
- STRYKER INC.
- Product Code
- MBB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940205 | CEMENT SIMPLEX ANTIBIOTIC BONE | BONE CEMENT, ANTIBIOTIC | MBB | STRYKER INC. | 61969001 | BHV0278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |