FDA Adverse Event
Malfunction
Summary report: N
UNKN PICO 7
MDR report key: 10063262
·
Received May 15, 2020
Report
- Report Number
- 8043484-2020-00456
- Event Type
- Malfunction
- Date Received
- May 15, 2020
- Date of Event
- April 21, 2020
- Report Date
- June 9, 2020
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- OMP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS A DUPLICATE OF REPORT 8043484-2020-00678. PLEASE REFER TO REPORT 8043484-2020-00678.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PICO 7 DEVICE PLACED ON A PATIENT TO TREAT A SURGICAL INCISION IN A COMPLICATED AREA ON (B)(6) 2020 STOPPED WORKING ON (B)(6) 2020. PATIENT IS GOING TO SEE DOCTOR UNTIL (B)(6), SO NO BACK-UP WAS AVAILABLE AT THE MOMENT OF THE FAILURE AND THERE WAS A GREAT DELAY IN TREATMENT. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524733 | UNKN PICO 7 | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | SMITH & NEPHEW MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |