FDA Adverse Event
Injury
Summary report: N
PROMETRA PROGRAMMABLE PUMP
MDR report key: 4938828
·
Received July 24, 2015
Report
- Report Number
- 3006803715-2015-00049
- Event Type
- Injury
- Date Received
- July 24, 2015
- Date of Event
- June 24, 2015
- Report Date
- June 25, 2015
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED AND WILL BE HANDLED PER HOSPITAL PROCEDURES. CORRECTION: THE MANUFACTURING DATE WAS INCORRECTLY ENTERED IN THE INITIAL MDR. THE CORRECT MANUFACTURING DATE FOR THE PUMP WAS 5/5/2015. INTERNAL COMPLAINT NUMBER: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN IRRITATION AT THE INCISION SITE. THE PUMP POCKET WAS INSPECTED AND IT WAS DETERMINED THAT THE IRRITATION WAS CONSISTENT WITH AN ALLERGIC REACTION. A PUMP EXPLANT WAS PERFORMED AND THE DEVICE WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE DEVICE WILL NOT BE RETURNED AND WILL BE HANDLED PER HOSPITAL PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482684 | PROMETRA PROGRAMMABLE PUMP | IMPLANTABLE INFUSION PUMP | LKK | FLOWONIX MEDICAL, INC | 13827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |