MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-23 for HITACHI MEDICAL SYSTEMS ME-RSC-120 manufactured by Hitachi Medical Corp.
[16219106]
On saturday, (b)(6) 2013, pt had an mri on left shoulder at the (b)(6). On (b)(6) 2013, the pt noticed her left should was red and started to blister. On (b)(6) 2013, pt contacted her primary care physician and was seen by her physician on tuesday, (b)(6) 2013. Pt was instructed to keep the area in question covered and to apply antibiotic ointment until the wound was closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3308767 |
| MDR Report Key | 3308767 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-16 |
| Date of Event | 2013-08-03 |
| Date Facility Aware | 2013-08-07 |
| Report Date | 2013-08-16 |
| Date Reported to FDA | 2013-08-16 |
| Date Added to Maude | 2013-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HITACHI MEDICAL SYSTEMS |
| Generic Name | OASIS RAPIID SHOULDER COIL |
| Product Code | MOS |
| Date Received | 2013-08-23 |
| Model Number | ME-RSC-120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI MEDICAL CORP |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-23 |