FDA Adverse Event
Malfunction
Summary report: N
RENASYS GO NPWT DEVICE
MDR report key: 6577695
·
Received May 19, 2017
Report
- Report Number
- 8043484-2017-00145
- Event Type
- Malfunction
- Date Received
- May 19, 2017
- Date of Event
- May 8, 2017
- Report Date
- July 18, 2017
- Manufacturer
- SMITH & NEPHEW MEDICAL LTD.
- Product Code
- OMP
- PMA / PMN Number
- K083375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS UNABLE TO CHARGE THE BATTERY OF RENASYS GO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360895 | RENASYS GO NPWT DEVICE | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | SMITH & NEPHEW MEDICAL LTD. | 66800164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |