FDA Adverse Event
Other
Summary report: N
BAND-AID BRAND SHEER COMFORT FLEX BAN
MDR report key: 821097
·
Received February 9, 2007
Report
- Report Number
- 2243656-2001-00002
- Event Type
- Other
- Date Received
- February 9, 2007
- Date of Event
- January 16, 2006
- Report Date
- February 9, 2007
- Manufacturer
- JOHNSON & JOHNSON CONSUMER COMPANIES INC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CONS WITH KNOWN LATEX ALLERGY PUT 2 BANDAIDS ON BELLY BUTTON/NOTICED ITCHING WITHIN MINUTES/2HRS LATER SHE REMOVED BANDAIDS AND HAD RED BLISTERS UNDER THE BANDAIDS/USED EPIPEN/DEVELOPED BEGINNING SIGNS OF THROAT CLOSING AND SOB/CONTACTED HCP BY PHONE/TX WITH AN INCREASED DOSE OF HER DAILY PREDNISONE/SX ABATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAND-AID BRAND SHEER COMFORT FLEX BAN | ADHESIVE BANDAGE | KGX | JOHNSON & JOHNSON CONSUMER COMPANIES INC | NA | 0455B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | PREDNISONE.| CLIMARA PATCH |