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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELLS MESH

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WELLS MESH Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Thrombosis (2100); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
Dvt developing with femoral veins moving to lungs or heart and/or cerebrum admission to hospital following on mri in the emergency room because of numbness in my left leg. Lack of ambulation associated with pain. Deep vein thromboses. Lack of ambulation associated with pain. Dvt movement throughout limbs.
 
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Brand NameWELLS MESH
Type of DeviceMESH
MDR Report Key6371611
MDR Text Key68980712
Report NumberMW5068200
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2017 Patient Sequence Number: 1
Treatment
ALBUTEROL INHALATION; ASPIRIN; DILAUDID 4MG; IBUPROFEN 200MG PRN; MORPHINE SULFATE 30MG; MULTIVITAMIN CENTRIUM
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