FDA Adverse Event
Malfunction
Summary report: N
HICOMBI DUAL PERFORMANCE TRANS
MDR report key: 17925721
·
Received October 11, 2023
Report
- Report Number
- MW5146880
- Event Type
- Malfunction
- Date Received
- October 11, 2023
- Date of Event
- September 1, 2023
- Report Date
- October 9, 2023
- Manufacturer
- HIMEDIA LABORATORIES PRIVATE LIMITED
- Product Code
- JSC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DETERMINATION OF CARBAPENEM RESISTANT ACINETOBACTER JUNII PRODUCING RARE CARBAPENEMASE ENZYME FOUND IN A TRANSPORT MEDIA BOTTLE FOR CS FLUIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1983356 | HICOMBI DUAL PERFORMANCE TRANS | CULTURE MEDIA, GENERAL NUTRIENT BROTH | JSC | HIMEDIA LABORATORIES PRIVATE LIMITED | LQF0006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |