FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER PREPERITONEAL DIST BALLOON
MDR report key: 2003091
·
Received February 8, 2011
Report
- Report Number
- 2647580-2011-00081
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 13, 2011
- Report Date
- January 13, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K935426
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: TEP TOTALLY EXTRAPERITONEAL. ACCORDING TO THE REPORTER: AIR LEAKED AND THE BALLOON COULD NOT BE INFLATED. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO PATIENT INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER PREPERITONEAL DIST BALLOON | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0F0734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |