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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LINVATEC / LINVATEC CORPORATION D/B/A DIGIT TRAP FINGER GRASPING DEVICE APPARATUS, TRACTION, NON-POWERED

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CONMED LINVATEC / LINVATEC CORPORATION D/B/A DIGIT TRAP FINGER GRASPING DEVICE APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 9906
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 06/22/2021
Event Type  malfunction  
Event Description
Product caused laceration to digit.
 
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Brand NameDIGIT TRAP FINGER GRASPING DEVICE
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
CONMED LINVATEC / LINVATEC CORPORATION D/B/A
1131 concept blvd
largo FL 33773
MDR Report Key12066661
MDR Text Key258732870
Report NumberMW5102137
Device Sequence Number1
Product Code HST
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9906
Device Catalogue Number9906
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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