FDA Adverse Event
Other
Summary report: N
STERION VESSEL LOOPS- MAXI, RED
MDR report key: 2987920
·
Received February 21, 2013
Report
- Report Number
- 1836161-2013-00016
- Event Type
- Other
- Date Received
- February 21, 2013
- Date of Event
- March 5, 2010
- Report Date
- February 21, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- DXC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL, METHOD: NO TESTING PERFORMED ON DEVICE. RESULTS: NO RESULTS AVAILABLE AS NO EVAL WAS PERFORMED. CONCLUSIONS- DEVICE WAS NOT MANUFACTURED BY ASPEN SURGICAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VESSEL LOOPS IN THEIR CUSTOM PACKS ARE INCONSISTENTLY A DARKER OR LIGHTER COLOR RED. THE DARKER RED APPEARS TO BE WEAKER AND IS BREAKING APART ALLOWING THE PATIENT TO BLEED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75217 | STERION VESSEL LOOPS- MAXI, RED | VESSEL LOOP | DXC | ASPEN SURGICAL PRODUCTS, INC. | 2009-08-24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |