FDA Adverse Event
Malfunction
Summary report: N
CURAPLEX
MDR report key: 18182212
·
Received November 21, 2023
Report
- Report Number
- 18182212
- Event Type
- Malfunction
- Date Received
- November 21, 2023
- Date of Event
- July 26, 2023
- Report Date
- September 26, 2023
- Manufacturer
- BOUND TREE MEDICAL, LLC
- Product Code
- OGK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CURAPLEX CURAVIEW LED LARYNGOSCOPE HANDLE AND BLADE SIZE 1 WAS NOTED TO HAVE A SMALL (APPROXIMATELY 1 CM) DARK BLUE PLASTIC PIECE IN THE PACKAGE. UPON OPENING THE PACKAGE, IT LOOKS AS THOUGH THE PIECE WAS BROKEN OFF THE HANDLE OF THE PRODUCT. PRODUCT WAS NOT USED AND WAS SEQUESTERED. OF NOTE: THIS LARYNGOSCOPE HANDLE AND BLADE IS NOT THE TYPICAL PRODUCT WE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1992450 | CURAPLEX | OROTRACHEAL INTUBATION GUIDE KIT | OGK | BOUND TREE MEDICAL, LLC | 301-LED-101M | 109424F0324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |