FDA Adverse Event
Other
Summary report: N
SEPARATOR SYSTEM UNIV SEAL 15MM X 150MM
MDR report key: 1141355
·
Received August 28, 2008
Report
- Report Number
- 2027111-2008-00036
- Event Type
- Other
- Date Received
- August 28, 2008
- Date of Event
- June 25, 2008
- Report Date
- August 27, 2008
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE ISSUED UPON COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
"DIFFICULT PROLONGED PROCEDURE. ON REMOVAL OF PORT VIEWED WITH THE TELESCOPE FROM INSIDE, THE END OF THE PORT WAS NOTICED TO BE CRACKED AND MISSING SOME PIECES. ABDOMEN WAS SEARCHED WITH TELESCOPE TO LOOK FOR ANY PIECES. SOME PIECES WERE RETRIEVED BUT A COUPLE OF SMALL PIECES COULD NOT BE FOUND."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEPARATOR SYSTEM UNIV SEAL 15MM X 150MM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |