FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER PREPERITONEAL DIST BALLOON
MDR report key: 1372666
·
Received February 19, 2009
Report
- Report Number
- 2647580-2009-00077
- Event Type
- Malfunction
- Date Received
- February 19, 2009
- Date of Event
- January 21, 2009
- Report Date
- January 27, 2009
- Manufacturer
- PONCE - USS
- Product Code
- GCJ
- PMA / PMN Number
- K946002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE INITIAL REPORT SENT: 02/19/2009.
Description of Event or Problem · 1
PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON POPPED. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER PREPERITONEAL DIST BALLOON | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | PONCE - USS | P5F1079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |