FDA Adverse Event
Other
Summary report: N
ACUSON
MDR report key: 2451051
·
Received December 15, 2011
Report
- Report Number
- 2936884-2011-00002
- Event Type
- Other
- Date Received
- December 15, 2011
- Date of Event
- November 9, 2011
- Report Date
- December 15, 2011
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- IYN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INTO THE ROOT CAUSE OF THE EVENT IS IN PROGRESS. ONCE THE INFO HAS BEEN GATHERED, A SEPARATE F/U REPORT WILL BE SUBMITTED TO FDA.
Description of Event or Problem · 1
DURING PROSTATE BIOPSY, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN PUTTING THE NEEDLE THROUGH THE PATH. DUE TO MULTIPLE ATTEMPTS, INCREASED PROSTATE BLEEDING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUSON | DIAGNOSTIC ULTRASOUND DEVICE | IYN | SIEMENS MEDICAL SOLUTIONS USA, INC. | BP9-4 NEEDLE GUIDE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |