FDA Adverse Event
Malfunction
Summary report: N
TUMESCENT INFILTRATION PUMP
MDR report key: 3773925
·
Received April 25, 2014
Report
- Report Number
- 2953189-2014-00053
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 25, 2014
- Report Date
- March 26, 2014
- Manufacturer
- COVIDIEN SAN JOSE
- Product Code
- FRN
- PMA / PMN Number
- K071588
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
Additional Manufacturer Narrative · 1
DEVICE HAS NOT RETURNED.
Description of Event or Problem · 1
CUSTOMER STATES THAT THE TUMESCENT INFILTRATION PUMP IS LEAKING FLUID.
Description of Event or Problem · 1
THE DP 20 WAS RETURNED TO NOUVAG USA INC. EVALUATION DETERMINED THAT THE FOOT PEDAL WAS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252565 | TUMESCENT INFILTRATION PUMP | PUMP, INFUSION | FRN | COVIDIEN SAN JOSE | TPMP-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |