FDA Adverse Event
Injury
Summary report: N
V.A.C. THERAPY
MDR report key: 3940136
·
Received June 19, 2014
Report
- Report Number
- 3009897021-2014-00063
- Event Type
- Injury
- Date Received
- June 19, 2014
- Report Date
- May 21, 2014
- Manufacturer
- KCI USA INC.
- Product Code
- OMP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO V.A.C. THERAPY. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE.
Description of Event or Problem · 1
KCI RECEIVED ARTICLE, ARMSTRONG, D.G., MARSTON, W.A., REYZELMAN, A.M., KIRSNER, R.S. COMPARISON OF NEGATIVE PRESSURE WOUND THERAPY WITH AN ULTRAPORTABLE MECHANICALLY POWERED DEVICE VS TRADITIONAL ELECTRICALLY POWERED DEVICE FOR THE TREATMENT OF CHRONIC LOWER EXTREMITY ULCERS: A MULTICENTER RANDOMIZED-CONTROLLED TRIAL. WOUND REP REG (2011) 173-180 THAT REPORTED THAT ONE PT PLACED ON V.A.C. THERAPY DEVELOPED AN INFECTION. NO ADD'L INFO IS AVAILABLE. THE UNIT'S TYPE OR SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVAL OF THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359495 | V.A.C. THERAPY | OMP | KCI USA INC. | WNDVAC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |