MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-16 for STELLANT DUAL CT INJECTOR 58746456 SCT D manufactured by Bayer Medical Care Inc..
[188649255]
This investigation remains in progress. Once the investigation is completed, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188649256]
The customer reported the following: after the completion of a procedure and upon removal of the syringes from the stellant ct injector, the technologist felt a shock sensation in her hands. As per hospital protocol, the employee was referred to a physician to be evaluated. The results of the evaluation were negative for any significant injury and the technologist was returned to full duty with no restrictions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00010 |
| MDR Report Key | 9835702 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2005-03-15 |
| Date Added to Maude | 2020-03-16 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE ECKERT |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal | 15051 |
| Manufacturer Phone | 7249408677 |
| Manufacturer G1 | BAYER MEDICAL CARE INC. |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLANT DUAL CT INJECTOR |
| Generic Name | CT INJECTION SYSTEM |
| Product Code | DXT |
| Date Received | 2020-03-16 |
| Model Number | 58746456 |
| Catalog Number | SCT D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER MEDICAL CARE INC. |
| Manufacturer Address | 1 BAYER DRIVE INDIANOLA PA 15051 US 15051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |