FDA Adverse Event
Injury
Summary report: N
FVC (FORCED VITAL CAPACITY) TEST
MDR report key: 19221446
·
Received April 30, 2024
Report
- Report Number
- MW5154455
- Event Type
- Injury
- Date Received
- April 30, 2024
- Date of Event
- April 26, 2024
- Report Date
- April 26, 2024
- Manufacturer
- UNKNOWN
- Product Code
- BZG
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PT (PATIENT) CANNOT TOLERATE THE TEST, EXTREME COUGHING. PAE (PATIENT ADVERSE EVENT) REPORTED BY (B)(6). (B)(6) DID CONSENT TO FOLLOW UP. (B)(6). NO FURTHER INFORMATION/ CLARIFICATION. AVAILABLE. (B)(4). NDC AND LOT NUMBERS: UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402603 | FVC (FORCED VITAL CAPACITY) TEST | SPIROMETER, DIAGNOSTIC | BZG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |