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 2018-12-11 for DURASEAL 5ML 1 KIT/BOX FOR JAPAN JDSD5001 manufactured by Integra Lifesciences Corp.
[129937966]
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.
Patient Sequence No: 1, Text Type: N, H10
[129937967]
A customer reported that due to a trauma, a decompression craniotomy was performed on the patient. Artificial dura mater was used. Two (2) boxes of duraseal jdsd5001 5ml 1 kit were used in subsequent cranioplasty. After surgery, patient's "level" fell in a few days. When head resurgence was resumed, about 100cc transparent jelly-like substance was stored outside the epidural space. Since it was unknown what had been stored without infection, it was speculated that it was the duraseal. Recovery was noted after removal. There was no delay due to the product issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00046 |
| MDR Report Key | 8151687 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2018-12-11 |
| 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 5ML 1 KIT/BOX FOR JAPAN |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-12-11 |
| 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 CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |