FDA Adverse Event
Other
Summary report: N
UNIVERSAL SET
MDR report key: 506227
·
Received January 13, 2004
Report
- Report Number
- 1423507-2004-00002
- Event Type
- Other
- Date Received
- January 13, 2004
- Report Date
- January 13, 2004
- Manufacturer
- CARDINAL HEALTH
- Product Code
- LRO
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SKIN-REACTIONS TO ADHESIVE AREA ON THE DRAPE. FIVE PTS DEVELOPED LOCAL SKIN IRRITATIONS AT THE AREA OF THE DRAPE. BONDING SURFACE FOLLOWING OUTPT SURGERY. THE PTS WERE TREATED ONLY WITH LOCAL BEPANTHEN SALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL SET | UNIVERSAL SET | LRO | CARDINAL HEALTH | 29114CE | 03HAC364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |