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 2018-12-10 for DURASEAL 5ML 5 KITS/BOX CE APPROVED DSD5005 manufactured by Integra Lifesciences Corp.
[129880237]
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. Linked to mfg report number: 1121308-2018-00105.
Patient Sequence No: 1, Text Type: N, H10
[129880238]
This is 2 of 2 reports. A regional sales manager reported on behalf of the customer that duragen rm dural regeneration matrix 3x3 was implanted in the posterior fossa and then they used duraseal 5ml on it on (b)(6) 2018. After two months, they saw leak collection. When they reopened the patient, they did not find the products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00047 |
| MDR Report Key | 8148944 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-10 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2018-12-10 |
| 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 5 KITS/BOX CE APPROVED |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-12-10 |
| Catalog Number | DSD5005 |
| Lot Number | N8A0014X |
| 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 | 2018-12-10 |