FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 17233570
·
Received June 29, 2023
Report
- Report Number
- 0002020735-2023-00001
- Event Type
- Injury
- Date Received
- June 29, 2023
- Report Date
- June 29, 2023
- Manufacturer
- AXIOM MEDICAL, INC.
- Product Code
- GBS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NO INFORMATION PROVIDED ON PART NUMBER OR LOT. DEVICE ALLEGEDLY AN AXIOM THORACIC CATHETER, 32 FR.
Description of Event or Problem · 0
IT WAS REPORTED TO BE A 32 FRENCH AXIOM THORACIC CATHETER, BUT NO DOCUMENTATION OR IMAGES OF THE CATHETER WERE PROVIDED. POST-SURGERY PATIENT REPORTED TO HAVE DEVELOPED TAMPONADE. SURGEON REMOVED CHEST TUBE AND FOUND IT FULL OF ONE CLOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1823361 | UNKNOWN | THORACIC CATHETER | GBS | AXIOM MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |