FDA Adverse Event
Malfunction
Summary report: N
SM PLUS BTT/OVAL BALLOON DISSECTOR
MDR report key: 2133263
·
Received May 11, 2011
Report
- Report Number
- 2647580-2011-00307
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 8, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K042412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: TEP INGUINAL HERNIA. ACCORDING TO THE REPORTER: BALLOON DID NOT DEPLOY. USED ANOTHER DEVICE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM PLUS BTT/OVAL BALLOON DISSECTOR | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0M1509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |