FDA Adverse Event
Injury
Summary report: N
ENVISION CT INJECTION SYSTEM
MDR report key: 2032604
·
Received March 23, 2011
Report
- Report Number
- 2520313-2011-00006
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- August 11, 2006
- Report Date
- February 22, 2011
- Manufacturer
- MEDRAD
- Product Code
- IZQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF OUR SERVICE RECORDS FOUND THAT A FUNCTIONAL CHECK OF THE INJECTOR WAS PERFORMED ON (B)(4), 2006. AT THE TIME OF THE SERVICE CALL, THE CUSTOMER DID NOT MENTION THE EXTRAVASATION EVENT. THE INJECTOR WAS PERFORMING TO MEDRAD SPECIFICATION.
Description of Event or Problem · 1
ON (B)(6), 2011, THE SITE REPORTED THE FOLLOWING LIMITED INFORMATION TO US: ON (B)(6), 2006, A PATIENT WITH AN ADMITTING DIAGNOSIS OF CHEST PAIN WAS UNDERGOING A CT SCAN OF THE CHEST. AN EXTRAVASATION REPORTEDLY OCCURRED. THE PATIENT DEVELOPED COMPARTMENTAL SYNDROME REQUIRING SURGICAL REPAIR AND PHYSICAL THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENVISION CT INJECTION SYSTEM | CT INJECTION SYSTEM | IZQ | MEDRAD | ECT 700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |