FDA Adverse Event
Death
Summary report: N
VERSAPOINT
MDR report key: 602786
·
Received May 16, 2005
Report
- Report Number
- 2210968-2005-00294
- Event Type
- Death
- Date Received
- May 16, 2005
- Date of Event
- April 5, 2005
- Report Date
- April 18, 2005
- Manufacturer
- ETHICON, INC.
- Product Code
- JOS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT A POLYPECTOMY OUTPATIENT PROCEDURE IN 2005. THREE TO FOUR POLYPS WERE REMOVED. TOWARDS THE END OF THE PROCEDURE, THE PATIENT FELT UNCOMFORTABLE WITH LOWER ABDOMINAL PAIN. THE PROCEDURE LENGTH WAS 20 MINUTES. FOLLOWING THE PROCEDURE, THE PATIENT WAS DISCHARGED WITH NO APPARENT COMPLICATIONS. PATIENT WAS RE ADMITTED THE NEXT DAY AND EXPIRED THE FOLLOWING DAY. A PERFORATION OF THE MID REGION OF THE SMALL BOWEL IN THE AREA DIRECTLY OVERLYING THE FUNDUS OF THE UTERUS WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSAPOINT | ELECTRODE | JOS | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |