FDA Adverse Event
Malfunction
Summary report: N
TUMESCENT INFILTRATION PUMP
MDR report key: 4140189
·
Received October 3, 2014
Report
- Report Number
- 2183870-2014-00246
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 28, 2014
- Manufacturer
- COVIDIEN-PLYMOUTH
- Product Code
- FRN
- PMA / PMN Number
- K071588
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.
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.
Description of Event or Problem · 1
NO PRESSURE WHEN FOOT PEDAL IS BEING USED FOR INFILTRATION OF TUMESCENT.INVESTIGATION OF THE PUMP ON (B)(6), 2014, DETERMINED THAT THE PUMP HEAD ASSEMBLY WAS DECTIVE,
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619476 | TUMESCENT INFILTRATION PUMP | PUMP, INFUSION | FRN | COVIDIEN-PLYMOUTH | TPMP-01 | 6385U1107R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |