FDA Adverse Event
Injury
Summary report: N
8F PRO-FUSE CT PLAST PORT
MDR report key: 2223927
·
Received August 18, 2011
Report
- Report Number
- 2518902-2011-00084
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 16, 2011
- Report Date
- August 17, 2011
- Manufacturer
- MEDCOMP
- Product Code
- LJT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SEPTUM SEPARATED FROM THE PORT BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8F PRO-FUSE CT PLAST PORT | POWER INJ. IMPLANTABLE INFUSION PORT | LJT | MEDCOMP | MRCTT80001 | MAVC140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |