MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-09-06 for DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 202050 manufactured by Integra Lifesciences Corp.
[120107117]
Integra has performed a thorough review of the reported incident. There was no product received back, as such only a dhr review was conducted. The dhr review concluded there were no assembly component related failures at the time of release. With the information provided a root cause could not be reliably determined. Should new information become available, the file will be re-opened and the investigation will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[120107118]
A distributor reported that on unspecified date, the doctor used an expired 202050 duraseal dural sealant system 5 ml in surgery. Additional information was received on 17aug2018 stating that the device was used on a brain tumor procedure. The procedure was performed successfully and there was no patient injury or surgery delay noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00039 |
| MDR Report Key | 7852970 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-16 |
| Date Mfgr Received | 2018-08-16 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-09-06 |
| Catalog Number | 202050 |
| Lot Number | N7A0597X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |