FDA Adverse Event
Injury
Summary report: N
UNKNOWN DURASEAL PRODUCT
MDR report key: 3836003
·
Received May 13, 2014
Report
- Report Number
- 1219930-2014-00367
- Event Type
- Injury
- Date Received
- May 13, 2014
- Report Date
- April 14, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- NQR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT SENT: 05/13/2014.
Description of Event or Problem · 1
ACCORDING TO THE RPTR: IN AN ARTICLE TITLED "BILATERAL NASOSEPTAL FLAPS FOR ENDOSCOPIC ENDONASAL TRANSSPHENOIDAL APPROACH" THE JOURNAL OF CRANIOFACIAL SURGERY, VOLUME 24, NUMBER 5, SEPTEMBER 2013, BY SHIN ET AL, THE USEFULNESS OF ELEVATING BILATERAL NASOSEPTAL FLAPS. AS PART OF THE TECHNIQUE, DURASEAL WAS USED. SIXTY-SEVEN PTS WERE INCLUDED IN THE STUDY. THERE WERE EIGHT PTS WHO UNDERWENT REOPERATIONS. OF THESE EIGHT PTS, ONE PT UNDERWENT THE REOPERATION FOR...
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288186 | UNKNOWN DURASEAL PRODUCT | SEALANT | NQR | COVIDIEN, FORMERLY US SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |