FDA Adverse Event
Malfunction
Summary report: N
YELLOPORT ELITE
MDR report key: 13265044
·
Received January 17, 2022
Report
- Report Number
- 9680952-2022-00002
- Event Type
- Malfunction
- Date Received
- January 17, 2022
- Date of Event
- January 13, 2022
- Report Date
- January 17, 2022
- Manufacturer
- SURGICAL INNOVATIONS LTD
- Product Code
- GCJ
- UDI-DI
- 05051986012438
- PMA / PMN Number
- K190592
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTED DATA TO "INITIAL" FROM "5 DAY."
Additional Manufacturer Narrative · 0
CORRECTED DATA TO "INITIAL" FROM "5 DAY". ATTACHED FINAL REPORT FROM THE INVESTIGATION.
Description of Event or Problem · 0
AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.
Description of Event or Problem · 0
AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.
Description of Event or Problem · 0
AFTER RECEIPT, THE CUSTOMER FOUND THAT THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1080236 | YELLOPORT ELITE | 12X75 PENCIL POINT TROCAR | GCJ | SURGICAL INNOVATIONS LTD | ET1207503 | 735479 | 05051986012438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |