MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-21 for DURASEAL 5ML 1 KIT/BOX FOR JAPAN JDSD5001 manufactured by Integra Lifesciences Corporation.
[117834902]
The device will not be 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. Linked to mfg report number: 3003418325-2018-00034.
Patient Sequence No: 1, Text Type: N, H10
[117834903]
This is 1 of 2 reports. It was reported that on (b)(6) 2018, a jdsd5001 duraseal 5ml 1 kit/box for (b)(6) was used on a sta-mca anastomosis. The surgery was finished without any problems but the patient had fever on the first day, postoperatively. The cause of fever was said to be unknown. However, there was no doubt of infection according to the test values. During surgery, duraseal was sprayed after the dural closure. The open area of the skull was about 5-6 cm in diameter. Duraseal usage was 1. 5cc - 2. 5cc. According to the surgeon, it was not likely that duraseal contacted with the cerebrum directly as the patient had dural defect and surgicel was used to close the defect part. Additional information received was on 01aug2018 re-stating that there was no possibility that duraseal was applied to the brain directly since it was applied after the dura closure. The patient was a (b)(6) male.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00033 |
| MDR Report Key | 7802985 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-21 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-08-21 |
| 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 CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| 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 5ML 1 KIT/BOX FOR JAPAN |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-08-21 |
| Catalog Number | JDSD5001 |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-21 |