MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for INJ. OPTIV DH, W/OEM 844007 manufactured by Liebel-flarsheim.
[105419765]
The contrast was injected, the psi "was fine", "there was no contrast enhancement inside the images". "the contrast was injected into her tissue and not into her veins" they were using opti-ray contrast. They stated the customer had some pain put a cold pack in the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00010 |
| MDR Report Key | 7421640 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2016-08-31 |
| Date Added to Maude | 2018-04-11 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| Manufacturer City | OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INJ. OPTIV DH, W/OEM |
| Generic Name | INJ. OPTIV DH, W/OEM |
| Product Code | IZQ |
| Date Received | 2018-04-11 |
| Model Number | 844007 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |