MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2015-08-18 for OPTIVANTAGE DH PEDESTAL STD W/ACCULINK V8411 manufactured by Liebel Flarsheim.
[23258747]
No quality defect was reported with the injector and no service visit was requested. Preventative maintenance on injector was last performed in june 2015. No similar issues with this unit have been found. No further investigation needed at this time.
Patient Sequence No: 1, Text Type: N, H10
[23258748]
An occurrence of extravasation and edema was reported involving an optivantage injector and an optiray 320 125ml pre-filled syringe. An injection of 60ml was made into the right forearm of a (b)(6) patient who was having an exam before their kidney surgery. The examination was not completed, the edema was treated (according the (b)(6) the treatment would be ice packs and maintaining the arm raised) and observed for approximately 4 hours, and the patient was released. The doctor and nurses of the hospital and was requested her to return 3 days after for evaluation. When the patient returned and was examined by the doctor, they were able to get the examination completed successfully. No additional details are known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2015-00082 |
| MDR Report Key | 5010329 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2015-08-18 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-07-29 |
| Device Manufacturer Date | 2014-05-31 |
| Date Added to Maude | 2015-08-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| 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 DH PEDESTAL STD W/ACCULINK |
| Generic Name | OPTIVANTAGE DH |
| Product Code | IZQ |
| Date Received | 2015-08-18 |
| Model Number | OPTIVANTAGE DH PEDESTAL STD W/ACCULINK |
| Catalog Number | V8411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL FLARSHEIM |
| Manufacturer Address | 2111 EAST GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-18 |