FDA Adverse Event
Injury
Summary report: N
COLLECTION SWAB & VIRUS SAMPLING TUBE
MDR report key: 10553050
·
Received September 17, 2020
Report
- Report Number
- MW5096725
- Event Type
- Injury
- Date Received
- September 17, 2020
- Date of Event
- September 4, 2020
- Report Date
- September 15, 2020
- Manufacturer
- JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD
- Product Code
- KXG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PATIENT WAS SWABBED ORAL PHARYNGEAL FOR COVID-19 AND WHEN PULLED OUT, THE TIP OF SWAB HAD BROKEN AND WAS MISSING. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011472 | COLLECTION SWAB & VIRUS SAMPLING TUBE | APPLICATOR, ABSORBENT TIPPED, STERILE | KXG | JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD | 20200502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |