MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-04-08 for OPTIVANTAGE BASE SYSTEM V8400 manufactured by Liebel-flarsheim.
[4466650]
During an abdomen/pelvis ct scan, a (b)(6) male patient ((b)(4)) experienced an extravasation of 70 ml of optiray 350. A pink catheter was used for injection and was tested by injecting 20 ml of physiological solution with no pain prior to contrast injection. The technologist monitored the patient during the injection of the contrast media at 2ml/sec and the patient did not report any pain and there was no arm swelling. The patient was treated with ice and arm elevation. On (b)(6)-2014, the patient was seen again and had recovered with no pain or edema.
Patient Sequence No: 1, Text Type: D, B5
[11866195]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2014-00034 |
| MDR Report Key | 3763555 |
| Report Source | 01,06,07 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-03-13 |
| Date Mfgr Received | 2014-03-13 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2014-04-24 |
| 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 | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIVANTAGE BASE SYSTEM |
| Generic Name | IZQ |
| Product Code | IZQ |
| Date Received | 2014-04-08 |
| Model Number | OPTIVANTAGE |
| Catalog Number | V8400 |
| Lot Number | CI0810B531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-08 |