FDA Adverse Event
Injury
Summary report: N
FLOWTRON/UNIVERSAL PUMPS
MDR report key: 2652080
·
Received June 28, 2012
Report
- Report Number
- 3005619970-2012-00005
- Event Type
- Injury
- Date Received
- June 28, 2012
- Date of Event
- May 31, 2012
- Report Date
- May 31, 2012
- Manufacturer
- GETINGE (SUZHOU) CO. LTD.
- Product Code
- JOW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(6) ON BEHALF OF THE MFR GETINGE (SUZHOU) CO LTD. MFR COMPLAINT# (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
"GROWING CONCERN AT THE NUMBER OF DVT/PE POSTOPERATIVE CASES WITH 20 IDENTIFIED THROUGH THE CARDIOVASCULAR SURGEONS ALONE. THIS HAS CONCERNED (B)(6) SO MUCH THEY ARE NOW HAVING IVC FILTERS PUT IN PROPHYLACTICALLY ON SOME PTS." (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOWTRON/UNIVERSAL PUMPS | JOW | GETINGE (SUZHOU) CO. LTD. | 507003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |