FDA Adverse Event
Injury
Summary report: N
BOWMAN LACRIMAL PROBE DOUBLE-ENDED, STAINLESS STELL 5-1/8"
MDR report key: 11744582
·
Received April 28, 2021
Report
- Report Number
- MW5101071
- Event Type
- Injury
- Date Received
- April 28, 2021
- Date of Event
- April 23, 2021
- Report Date
- April 27, 2021
- Product Code
- HNL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LACRIMAL PROBE BROKE DURING USE LEAVING A SMALL LINEAR MENTAL FRAGMENT THAT HAD TO BE REMOVED IN 2ND SURGERY. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638595 | BOWMAN LACRIMAL PROBE DOUBLE-ENDED, STAINLESS STELL 5-1/8" | PROBE, LACHRYMAL | HNL | AZ1905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |