FDA Adverse Event
Malfunction
Summary report: N
TRAPEZOID RX
MDR report key: 16302788
·
Received February 6, 2023
Report
- Report Number
- 3005099803-2023-00248
- Event Type
- Malfunction
- Date Received
- February 6, 2023
- Date of Event
- January 10, 2023
- Report Date
- February 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LQC
- UDI-DI
- 08714729296409
- PMA / PMN Number
- K040447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WAS REPORTED BY BSC SALES REP. THE INITIAL REPORTER FACILITY NAME IS: (B)(6). DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF TEAR, RIP OR HOLE IN DEVICE PACKAGING.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE DEVICE PACKAGING OF A TRAPEZOID BASKET HAS A HOLE AND WAS SLIGHTLY WORN OUT ON (B)(6) 2023. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99767 | TRAPEZOID RX | LITHOTRIPTOR, BILIARY MECHANICAL | LQC | BOSTON SCIENTIFIC CORPORATION | M00510890 | 0030442149 | 08714729296409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |