FDA Adverse Event
Injury
Summary report: N
SPACEMAKER PREPERITONEAL DIST BALLOON
MDR report key: 2202341
·
Received August 3, 2011
Report
- Report Number
- 2647580-2011-00507
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 13, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K935426
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: PREPERITONEAL HERNIA REPAIR. ACCORDING TO THE REPORTER: DURING THE CASE, THE BALLOON BROKE AND PIECES FELL IN TO THE CAVITY. THE SURGEON WAS FORCED TO DELAY THE PROCEDURE BY 45 MINUTES TO LOOK FOR THE PIECE OF THE BALLOON WHICH HAD POPPED. 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 | USSC PUERTO RICO | P9D0285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |