FDA Adverse Event
Malfunction
Summary report: N
OLLIF TRAY FLEXIBLE HOOP CUTTER, DISC CUTTE
MDR report key: 15446157
·
Received September 16, 2022
Report
- Report Number
- MW5112102
- Event Type
- Malfunction
- Date Received
- September 16, 2022
- Date of Event
- September 14, 2022
- Report Date
- September 14, 2022
- Manufacturer
- ADVANCED RESEARCH MEDICAL LLC
- Product Code
- LRP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WHILE USING THE PRODUCT, THE PRODUCT BROKE. ALL PIECES WERE ACCOUNTED FOR. FDA SAFETY REPORT ID #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125981 | OLLIF TRAY FLEXIBLE HOOP CUTTER, DISC CUTTE | TRAY, SURGICAL | LRP | ADVANCED RESEARCH MEDICAL LLC | 01-06-4REVA | BD083AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Unknown | Other |