FDA Adverse Event
Malfunction
Summary report: N
SPACEMAKER PREPERITONEAL DIST BALLOON
MDR report key: 2864741
·
Received November 9, 2012
Report
- Report Number
- 2647580-2012-00710
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 18, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GCJ
- PMA / PMN Number
- K935426
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: INGUINAL HERNIA REPAIR/TEP. ACCORDING TO THE REPORTER: UPON USING, IT WAS NOTICED THE TIP OF THE DISTAL END OF DEVICE WAS MISSING. NO BLEEDING. NO TISSUE DAMAGE. NOTHING FELL INTO CAVITY. NO PATIENT HARM. OPERATING ROOM TIME NOT EXTENDED. THE DEFECTIVE WAS DISCARDED AT THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACEMAKER PREPERITONEAL DIST BALLOON | SPACEMAKER BALLOON | GCJ | COVIDIEN, FORMERLY USSC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |