FDA Adverse Event
Injury
Summary report: N
1223688-1999-00039
MDR report key: 257517
·
Received December 28, 1999
Report
- Report Number
- 1223688-1999-00039
- Event Type
- Injury
- Date Received
- December 28, 1999
- Date of Event
- November 13, 1999
- Report Date
- December 1, 1999
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DOME WAS DETACHED IN PTS STOMACH. THIS INCIDENT OCCURRED WHEN THE "NBR" WAS ATTEMPTED TO EXCHANGE. THE CATHETER WAS IN PLACE FOR 270 DAYS. THE DOME WAS REMOVED FROM THE PT BY USING RESECT SCOPE AND UNKNOWN RETRIEVAL DEVICE.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |