FDA Adverse Event
Other
Summary report: N
BRUSH
MDR report key: 19148
·
Received January 25, 1995
Report
- Report Number
- MW1004857
- Event Type
- Other
- Date Received
- January 25, 1995
- Date of Event
- December 21, 1994
- Report Date
- January 14, 1995
- Manufacturer
- MEDICAL PACKAGING CORP.
- Product Code
- GEE
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
AFTER OB/GYN USED NEW BRUSH TEST FOR ANNUAL PAP SMEAR, RPTR BLED (MODERATELY-2 PADS OR TAMPONS A DAY) FOR FIVE DAYS. SHE BEGAN BLEEDING IMMEDIATELY. HER OB/GYN SAID SHE WOULD BLEED "FOR A BIT", BUT RPTR STATED FIVE DAYS IS RATHER EXCESSIVE FOR A PAP SMEAR. RPTR FEELS THERE MUST BE A BETTER WAY TO ASSURE A GOOD PAP SMEAR SPECIMAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRUSH | GEE | MEDICAL PACKAGING CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |