FDA Adverse Event
Injury
Summary report: N
CEMENT
MDR report key: 23726457
·
Received December 4, 2025
Report
- Report Number
- MW5179924
- Event Type
- Injury
- Date Received
- December 4, 2025
- Date of Event
- October 1, 2025
- Report Date
- December 2, 2025
- Manufacturer
- HERAEUS MEDICAL LLC
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6)NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. CLINICAL ADVERSE EVENT RECEIVED FOR HOSPITALISED FOR CHEST INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. 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 |
|---|---|---|---|---|---|---|---|
| 2438694 | CEMENT | BONE CEMENT | LOD | HERAEUS MEDICAL LLC | 67681283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |