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 2018-09-27 for DURASEAL 5ML 1 KIT/BOX FOR JAPAN JDSD5001 manufactured by Integra Lifesciences Corp.
[121887369]
The device is not expected to 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
[121887370]
The customer reported that a jdsd5001 duraseal 5ml 1 kit/box was used in a cranioplasty procedure on an unknown date. In that patient, the number of blood spheres increased and became meningitis. It was reported that the doctor needed a sample product for patch testing to see whether duraseal was the cause or not. There was an enlargement of surgical wounds less than 3 centimeters (cm) that has been carried out. Patient is under observation. Additional information was received on 18sep2018 indicating that the duraseal was implanted in (b)(6) 2018. During surgery, the product was used without any problems. The blood sphere increase was noted on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00041 |
| MDR Report Key | 7914348 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-09-02 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2018-09-27 |
| 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 | 2018-09-27 |
| Catalog Number | JDSD5001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-09-27 |