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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MICROMYST APPLICATOR SYRINGE, PISTON

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INTEGRA LIFESCIENCES CORPORATION MICROMYST APPLICATOR SYRINGE, PISTON Back to Search Results
Model Number 205000DS
Device Problems Use of Device Problem (1670); Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 05/28/2021
Event Type  malfunction  
Event Description
Duraseal system - exact spine sealant system polymer kit / and micromyst applicator were unable to express the duraseal polymer product. The syringe plungers were unable to be advanced. Fda safety report id # (b)(4).
 
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Brand NameMICROMYST APPLICATOR
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
princeton NJ 08540
MDR Report Key11929873
MDR Text Key254377338
Report NumberMW5101682
Device Sequence Number2
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/01/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number205000DS
Device Catalogue Number205000DS
Device Lot Number2021010572
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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