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 DURAGEN RM DURAL REGENERATION MATRIX 3X3 DRM1033I manufactured by Integra Lifesciences Corporation.
[129935174]
The product has not returned back for failure analysis as it has been used in surgery. Per dhr review, the duragen secure product lot 2664480 was released based on passing of all in process and finished goods criteria. Complaint is unconfirmed. The root cause is undetermined. As per the complaint description, both duragen secure (also known as duragen rm) and duraseal products were used. Therefore, it is difficult to know what exactly contributed to the leak collection. Linked to mfg. Report number: 3003418325-2018-00047.
Patient Sequence No: 1, Text Type: N, H10
[129935175]
This is 1 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. Additional information received on (b)(6) 2018 with the following: the (b)(6) male patient arrived at the hospital without any deficit, just few "walk deficit" caused from the benign tumor. The patient had a good outcome after the procedure. After two (2) months, the patient came back at the hospital because of the fistula, which was treated immediately. It was noted that when the doctor retreated the patient for the fistula after 2 months, the doctor didn? T find any trace of duragen. It was reported that currently, the patient is okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00105 |
| MDR Report Key | 8151480 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2018-07-27 |
| 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 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 | DURAGEN RM DURAL REGENERATION MATRIX 3X3 |
| Generic Name | DURAGEN SECURE |
| Product Code | GXQ |
| Date Received | 2018-12-11 |
| Catalog Number | DRM1033I |
| Lot Number | 2664480 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-12-11 |