DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-04 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corp.

Event Text Entries

[140906374] 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


[140906375] A female patient reported that her doctor used? A lot? Of duraseal product during spinal surgery on (b)(6) 2019. The doctor did not specify an amount used. The exact product id of the duraseal was not known; not sure if the 3ml (206320) or 5ml (206520). The patient stated she was in extreme pain and had trouble walking or standing. The date of the event was not specified. The patient was seeking to know how long it takes for the product to absorb into her body as the pain was unbearable. Additional information has been requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003418325-2019-00008
MDR Report Key8482352
Report SourceCONSUMER
Date Received2019-04-04
Date of Report2019-03-12
Date Mfgr Received2019-04-05
Date Added to Maude2019-04-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES CORP
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal Code08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURASEAL XACT, UNKNOWN
Generic NameDURASEAL SPINE
Product CodeNQR
Date Received2019-04-04
Catalog NumberXXX-DURASEAL XACT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP
Manufacturer Address311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-04

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