FDA Adverse Event
Injury
Summary report: N
PICO
MDR report key: 5216997
·
Received November 11, 2015
Report
- Report Number
- 8043484-2015-00294
- Event Type
- Injury
- Date Received
- November 11, 2015
- Date of Event
- November 2, 2015
- Report Date
- November 2, 2015
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- OMP
- PMA / PMN Number
- K112127
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SMITH & NEPHEW, MEDICAL LTD. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD 3 SMALL BLISTER AROUND UMBILICUS AFTER APPLICATION OF PICO FOR 5 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748631 | PICO | POWERED SUCTION PUMP | OMP | SMITH & NEPHEW MEDICAL LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |