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 2019-05-23 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corp.
[146043074]
It is unknown if the device involved will be returned to the manufacturer for evaluation. 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
[146043075]
An integra manager reported on behalf of the customer that duraseal (xxx-duraseal xact) caused a negative change in somatosensory evoked potential (ssep) on an unspecified date. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3003418325-2019-00018 |
MDR Report Key | 8638675 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-05-23 |
Date of Report | 2019-04-29 |
Date Mfgr Received | 2019-06-25 |
Date Added to Maude | 2019-05-23 |
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 XACT, UNKNOWN |
Generic Name | DURASEAL SPINE |
Product Code | NQR |
Date Received | 2019-05-23 |
Catalog Number | XXX-DURASEAL XACT |
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 | 2019-05-23 |