MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-02 for DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5 206320 manufactured by Integra Lifesciences Corp.
[143852589]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[143852590]
A sales representative reported on behalf of the customer that a 206320 duraseal exact spine sealant system 3ml hardened to a light blue coating on the dura on (b)(6) 2019 they ended up using three duraseal. On the first package used, the blue liquid was inserted into the powder as directed and then completely solidified. The scrub nurse was unable to draw it back up into the syringe. The second and third duraseal were able to be drawn up and used on the patient but the product hardened to a light blue coating on the dura. The device was in contact with the patient with no known patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00013 |
| MDR Report Key | 8574072 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-06-25 |
| Device Manufacturer Date | 2018-11-20 |
| Date Added to Maude | 2019-05-02 |
| 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 EXACT SPINE SEALANT SYSTEM 3ML US BOX OF 5 |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2019-05-02 |
| Catalog Number | 206320 |
| Lot Number | 60159631 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-02 |