FDA Adverse Event
Malfunction
Summary report: N
SM PLUS BTT/ROUND BALLOON DISSECTOR
MDR report key: 1760208
·
Received July 12, 2010
Report
- Report Number
- 2647580-2010-00609
- Event Type
- Malfunction
- Date Received
- July 12, 2010
- Date of Event
- June 9, 2010
- Report Date
- June 9, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GCJ
- PMA / PMN Number
- K042412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE INITIAL REPORT SENT: (B)(6) 2010.
Description of Event or Problem · 1
PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE RPTR: THE BALLOON DID NOT INFLATE. THERE WAS NO REPORT OF UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM PLUS BTT/ROUND BALLOON DISSECTOR | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | USSC PUERTO RICO | P0D0444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |