FDA Adverse Event
Malfunction
Summary report: N
PICO SINGLE USE NPWT 15 X 15CM
MDR report key: 4994567
·
Received August 12, 2015
Report
- Report Number
- 8043484-2015-00240
- Event Type
- Malfunction
- Date Received
- August 12, 2015
- Date of Event
- July 14, 2015
- Report Date
- July 15, 2015
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- OMP
- PMA / PMN Number
- K112127
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITH & NEPHEW HAS ERRONEOUSLY INFORMED THE FDA OF THIS INCIDENT TWICE, ONCE VIA THIS REPORT AND ONCE IN COMPLAINT REF 8043484-2015-00242. SMITH & NEPHEW WILL CLOSE THIS COMPLAINT (8043484-2015-00240) AS A DUPLICATE, AND CONFIRM THAT WE WILL SUBMIT A FOLLOW UP REPORT IF NEW INFORMATION BECOMES AVAILABLE USING 8043484-2015-00242.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE FAILED TO ALARM ON A PATIENT AFTER 1 DAY OF USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530110 | PICO SINGLE USE NPWT 15 X 15CM | POWERED SUCTION PUMP | OMP | SMITH & NEPHEW MEDICAL LTD. | 66800954 | 1404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 02 YR |