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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK PA, INC. RUGGLES KERRISON 1MM RONGEUR, MANUAL

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INTEGRA YORK PA, INC. RUGGLES KERRISON 1MM RONGEUR, MANUAL Back to Search Results
Model Number 1MM
Device Problem Failure to Cut (2587)
Patient Problem No Information (3190)
Event Date 01/23/2019
Event Type  malfunction  
Event Description
Integra ruggles kerrisons purchased and used. Upon the first time using them, none of them were able to cut tissue.
 
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Brand NameRUGGLES KERRISON 1MM
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
INTEGRA YORK PA, INC.
MDR Report Key8292873
MDR Text Key135004619
Report NumberMW5083545
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/28/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MM
Device Catalogue NumberRD41191D1
Device Lot Number100161-1803
Was Device Available for Evaluation? Yes
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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