FDA Adverse Event
Summary report: N
DURASEAL
MDR report key: 1645866
·
Received March 26, 2010
Report
- Report Number
- 1645866
- Date Received
- March 26, 2010
- Date of Event
- January 29, 2010
- Report Date
- March 12, 2010
- Manufacturer
- CONFLUENT SURGICAL, INC.
- Product Code
- NQR
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT RIGHT SIDE DISCECTOMY. DURASEAL & DURAGEN EMPLOYED DURING SURGERY. IN POST-OPERATIVE PERIOD PATIENT DEVELOPED SEVERE RIGHT SIDED PAIN PREVENTING MOBILITY. SYMPTOMS RESPONDED WITH ORAL STEROIDS. AFTER SEVERAL DAYS AT HOME THE PATIENT'S PAIN RETURNED AND WAS MUCH MORE INTENSE. IMAGING REVEALED SUBSTANTIAL PRESSURE ON DURAL SAC WITH WHAT APPEARED TO BE A HUGELY EXPANDED VOLUME OF DURASEAL. THE PATIENT SUBSEQUENTLY UNDERWENT A RE-EXPLORATION AND UPON ENCOUNTERING DURASEAL IT WAS NOTED TO BE SOFT AND GELATINOUS & WAS WITHOUT FIRM CONSISTENCY. THE DURAGEN HAD BEEN COMPLETELY DISPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURASEAL | SEALANT, DURAL; CSF LEAK SEALANT | NQR | CONFLUENT SURGICAL, INC. | * | CO82895-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |