FDA Adverse Event
Malfunction
Summary report: N
BELLA BLANKETS
MDR report key: 2658995
·
Received July 5, 2012
Report
- Report Number
- 9021987-2012-00003
- Event Type
- Malfunction
- Date Received
- July 5, 2012
- Date of Event
- November 22, 2011
- Report Date
- July 4, 2012
- Manufacturer
- BEEKLEY CORPORATION
- Product Code
- IZH
- PMA / PMN Number
- 073262
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REPORT 9021987-2012-00001 INDICATED 2 PATIENT REPEATED IMAGES OF MAMMOGRAMS. WE NOW REALIZE THAT A REPORT NEEDED TO BE FILED FOR EACH PATIENT, SO THIS IS A SECOND REPORT FOR THE 2ND PATIENT.
Description of Event or Problem · 1
BELLA BLANKETS PROTECTIVE COVERLETS CONTAINED A MATERIAL COMPONENT WHICH COULD HAVE IMAGED AS ARTIFACT ON A PATIENT MAMMOGRAM. THIS COMPONENT OF THE PRODUCT CAUSED A HONEYCOMB OR DIAMOND-PATTERN ARTIFACT TO APPEAR ON 2 PATIENT IMAGES WHICH WAS NOTICED BY THE RADIOLOGIST, RESULTING IN 2 REPEAT MAMMOGRAM IMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BELLA BLANKETS | X-RAY SYSTEM, MAMMOGRAPHY | IZH | BEEKLEY CORPORATION | 311 | 107657, 108-833/850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |