FDA Adverse Event
Injury
Summary report: N
DRYSDALE NUCLEUS MANIPULATOR
MDR report key: 10494288
·
Received September 3, 2020
Report
- Report Number
- MW5096445
- Event Type
- Injury
- Date Received
- September 3, 2020
- Date of Event
- August 20, 2020
- Report Date
- September 1, 2020
- Manufacturer
- UNK
- Product Code
- HNQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
TIP OF INSTRUMENT BROKE OFF IN PATIENT'S OPERATIVE EYE. (B)(6). FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 956720 | DRYSDALE NUCLEUS MANIPULATOR | HOOK, OPHTHALMIC | HNQ | UNK | 86-1752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |