FDA Adverse Event
Injury
Summary report: N
VISITEC
MDR report key: 13122825
·
Received December 30, 2021
Report
- Report Number
- 3002808441-2021-00011
- Event Type
- Injury
- Date Received
- December 30, 2021
- Date of Event
- December 8, 2021
- Report Date
- December 30, 2021
- Manufacturer
- BEAVER VISITEC INTERNATIONAL LIMITED
- Product Code
- HMX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Additional Manufacturer Narrative · 0
NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT THE NEEDLE OF THE RYCROFT CANNULA SEPARATED FROM THE BASE. THE CUSTOMER ALLEGED THAT THERE WAS INJURY TO THE EYE OF THE PATIENT. ((B)(4)).
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT THE NEEDLE OF THE RYCROFT CANNULA SEPARATED FROM THE BASE. THE CUSTOMER ALLEGED THAT THERE WAS INJURY TO THE EYE OF THE PATIENT. ((B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2014511 | VISITEC | VISITEC 30GX22MM RYCROFT CANNULA | HMX | BEAVER VISITEC INTERNATIONAL LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |