FDA Adverse Event
Injury
Summary report: N
CENTRAL LINE DRESSING KIT (SPECIFICALLY THE NON-ADHERENT PAD)
MDR report key: 14958248
·
Received July 7, 2022
Report
- Report Number
- MW5110761
- Event Type
- Injury
- Date Received
- July 7, 2022
- Report Date
- July 6, 2022
- Manufacturer
- TRINITY STERILE, INC.
- Product Code
- OXQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PATIENT INADVERTENTLY USED LATEX CONTAINING PRODUCT. EXPERIENCING SYMPTOMS SUCH AS ITCHINESS, BURNING SENSATION, "WEIRD FEELING," AND "REALLY BOTHERSOME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1908283 | CENTRAL LINE DRESSING KIT (SPECIFICALLY THE NON-ADHERENT PAD) | DRESSING CHANGE TRAY | OXQ | TRINITY STERILE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |