MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-11 for BIOGRAPH MMR 10433372 manufactured by Siemens Healthcare.
[4706559]
It was reported to siemens that while performing an mr pet examination, a female subject with large breasts complained of burns on her breast. It was reported that the spine coil, as well as two body matrix coils, were used during the examination. The left breast was observed to be warm to the touch, but not tender and no blister was present. The right breast was observed to be warm to the touch, tender to palpation and a small blister was present. The subject was treated with topical ointment. The study was approximately 2 hours in length.
Patient Sequence No: 1, Text Type: D, B5
[12308682]
An investigation is currently underway. No system or coil malfunction has been found to date. Siemens will continue further investigation of the system coils to determine root cause. A supplement report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2014-06205 |
| MDR Report Key | 4003114 |
| Report Source | 06 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-24 |
| Device Manufacturer Date | 2011-06-06 |
| Date Added to Maude | 2014-08-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MEREDITH ADAMS |
| Manufacturer Street | 51 VALLEY STREAM PARKWAY, D02 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104483237 |
| Manufacturer G1 | SIEMENS AG |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGRAPH MMR |
| Generic Name | TOMO IMAGER WITH NUC. MAG. RES |
| Product Code | OUO |
| Date Received | 2014-08-11 |
| Model Number | 10433372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY, D02 MALVIN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-11 |