FDA Adverse Event
Malfunction
Summary report: N
BEMIS 2000CC HI-FLOW SUCTION CANISTER
MDR report key: 3190594
·
Received June 13, 2013
Report
- Report Number
- 2133713-2013-00010
- Event Type
- Malfunction
- Date Received
- June 13, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 12, 2013
- Manufacturer
- BEMIS MFG. COMPANY
- Product Code
- GCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
USE OF THIS PRODUCT IN LIPOSUCTION IS CONTRAINDICATED IN INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. REP WAS ADVISED TO PASS THAT INFORMATION ON VIA (B)(4) REP AND ADVISE CONVERSION TO SOFT LINER PRODUCT.
Description of Event or Problem · 1
OUR SALES REP WAS CONTACTED BY A (B)(6) REP INFORMING HIM THAT (B)(4) OF PLASTIC SURGERY REPORTED AN IMPLOSION OF (B)(4) DURING LIPOSUCTION. THERE WERE NO PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270358 | BEMIS 2000CC HI-FLOW SUCTION CANISTER | APPARATUS, VACUUM, SUCTION POWERED | GCX | BEMIS MFG. COMPANY | 494410 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |