FDA Adverse Event
Injury
Summary report: N
UNK DURASEAL PRODUCT
MDR report key: 3964880
·
Received July 18, 2014
Report
- Report Number
- 1219930-2014-00547
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 18, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- NQR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LUMBAR LAMINECTOMY WITH DISCECTOMY. LITERATURE REVIEW: ACCORDING TO THE AUTHORS OF THE ARTICLE "POSTOPERATIVE CERVICAL CORD COMPRESSION INDUCED BY HYDROGEL DURAL SEALANT" THERE WAS A CASE REPORTED OF DURASEAL CAUSING CAUDA EQUINA COMPRESSION AFTER A PT UNDERWENT A LUMBAR LAMINECTOMY AND DISCECTOMY COMPLICATED BY A DURAL TEAR. THE PT'S TEAR WAS TREATED WITH DURASEAL AND THE PT DEVELOPED SYMPTOMS OF CAUDA EQUINA COMPRESSION 9 DAYS POST-OP. EMERGENT EXPLORATION AND DECOMPRESSION REVEALED A LARGE AMOUNT OF BLUE DURASEAL WAS VISUALIZED AND THE VOLUME REMOVED MEASURED 10ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423443 | UNK DURASEAL PRODUCT | HYDROGEL DURAL SEALANT | NQR | COVIDIEN, FORMERLY US SURGICAL | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |