MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-01-31 for SENSE BREAST 3.0T 4535-302-64711 manufactured by Invivo Corporation.
[4464241]
The customer reported that during a test of an mri breast protocol with the new mammocoil on the philips pet/mri, a patient was positioned on the coil and the table was moved into the mri tunnel using the "travel to scanplane" button. During the movement of the table to the scanning position, the patient became trapped between the coil and the top of the bore. The patient indicated pain and was immediately removed from the bore. A few days later the patient was diagnosed with a broken rib.
Patient Sequence No: 1, Text Type: D, B5
[11737613]
(b)(4): eval method: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda. Eval results: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda. Conclusion: the investigation is still ongoing on this event. When the investigation is completed a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2014-00001 |
| MDR Report Key | 3750732 |
| Report Source | 08 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-07 |
| Date Mfgr Received | 2014-01-20 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-04-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH RAVENNAUGH, DIR |
| Manufacturer Street | 3545 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523360010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSE BREAST 3.0T |
| Generic Name | NA |
| Product Code | MOS |
| Date Received | 2014-01-31 |
| Model Number | 4535-302-64711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 3545 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-31 |