FDA Adverse Event
Other
Summary report: N
OHIO MEDICAL NPWT WOUND CARE KIT
MDR report key: 1674679
·
Received May 3, 2010
Report
- Report Number
- 1419185-2010-13602
- Event Type
- Other
- Date Received
- May 3, 2010
- Date of Event
- December 1, 2009
- Report Date
- May 3, 2010
- Manufacturer
- OHIO MEDICAL CORPORATION
- Product Code
- OMP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE PT HAD AN ALLERGIC REACTION TO TEGADERM TRANSPARENT FILM DRESSING WHICH IS A MOBLVAC NEGATIVE PRESSURE WOUND THERAPY (NPWT) KIT COMPONENT. THE PT EXPERIENCED FLUID FILLED BLISTERS APPROX ONE MONTH AFTER THE APPLICATION OF THE MOBLVAC AROUND THE EDGES OF THE TRANSPARENT DRESSING, (BUT NOT UNDER THE DRESSING). USE OF THE MOBLVAC ON THIS PT WAS DISCONTINUED AND A NEW MODALITY WAS STARTED. THE PT'S WOUND IS CURRENTLY HEALING WITH DIFFICULTY AND THE BLISTERS RESOLVED WITHOUT ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OHIO MEDICAL NPWT WOUND CARE KIT | NPWT WOUND CARE KIT | OMP | OHIO MEDICAL CORPORATION | 769802 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | PATIENT UNDER HOME HEALTH CARE BY RN. |