FDA Adverse Event
Other
Summary report: N
XCELA LOW PROFILE PORT
MDR report key: 1613100
·
Received February 17, 2010
Report
- Report Number
- 2032582-2010-00001
- Event Type
- Other
- Date Received
- February 17, 2010
- Date of Event
- January 18, 2010
- Report Date
- February 17, 2010
- Manufacturer
- PFM MEDICAL, INC
- Product Code
- LJT
- PMA / PMN Number
- K073210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BIOCOMPATIBILITY TEST FOR THE DEVICE HAS BEEN REVIEWED. DEVICE PASSED BOTH IRRITATION AND SENSITIVITY TESTS ISO (B)(4). DATA IS AVAILABLE UPON REQUEST. PFM MEDICAL HAS MADE MULTIPLE ATTEMPTS TO RETRIEVE ADD'L PT INFO WITH NO SUCCESS. (B)(6). (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT DEVELOPED A BODY RASH WITHIN THE FIRST WEEK AFTER THE PORT WAS PLACED. ALSO, PT REC'D FIRST INFUSION OF CHEMO THAT WEEK. DOCTOR IS AWARE OF THE CONDITION. PT WENT TO SEE DERMATOLOGIST, AND THE SOURCE OF THE RASH IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XCELA LOW PROFILE PORT | IMPLANTED PORT AND CATHETER SYSTEM | LJT | PFM MEDICAL, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |