MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for MRI - BREAST COIL manufactured by .
[65964893]
I had a double mastectomy with no reconstruction (b)(6) 2016. I have lymphedema in my left arm and have a compression sleeve. In (b)(6) 2016 a follow-up breast mri was ordered. Because i have no breasts they used some devices to tightly position me in the coil. Being squashed in that prone position for over half-an-hour has damaged my ulnar nerve in my left arm and i know have cubital tunnel syndrome. I do not know if it will get better and it could be permanent. I am left-handed so it is a significant problem for me. I am dictating this to my husband because i cannot write. Nine years old at (b)(6) (prelman center): position: prone, head first. Room 1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067483 |
| MDR Report Key | 6279381 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-15 |
| Date of Event | 2016-12-23 |
| Date Added to Maude | 2017-01-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MRI - BREAST COIL |
| Generic Name | MRI - BREAST COIL |
| Product Code | MOS |
| Date Received | 2017-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-01-24 |