MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for DURASEAL DURAL SEALANT SYSTEM 202050 manufactured by Integra Lifesciences Corporation.
[138213742]
Product placed during spine surgery procedure. Upon follow up appointment patient had imaging studies which demonstrated duraseal product had expanded and caused cauda equina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8403132 |
| MDR Report Key | 8403132 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-22 |
| Report Date | 2019-03-06 |
| Date Reported to FDA | 2019-03-06 |
| Date Reported to Mfgr | 2019-03-08 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL DURAL SEALANT SYSTEM |
| Generic Name | SEALANT, DURAL |
| Product Code | NQR |
| Date Received | 2019-03-08 |
| Model Number | 202050 |
| Catalog Number | 202050 |
| Lot Number | N8A1127X |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |