FDA Adverse Event
Malfunction
Summary report: N
DURASEAL SPINE SEALANT 2ML XTA
MDR report key: 2478390
·
Received February 16, 2012
Report
- Report Number
- 1219930-2012-00146
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Date of Event
- November 3, 2011
- Report Date
- January 17, 2012
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- NQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PT EXPERIENCED A SUBCUTANEOUS SEROMA. CT SCAN WAS PERFORMED AND A STERILE DRAINAGE OF THE SEROMA OCCURRED ON (B)(6) 2011. RELATIONSHIP TO DEVICE: POSSIBLE RELATIONSHIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURASEAL SPINE SEALANT 2ML XTA | DURASEAL SPINE SEALANT 2ML XTA | NQR | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |