MAUDE Adverse Event Report: WELLS MESH

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.

• Brand Name: WELLS MESH
• Type of Device: MESH
• MDR Report Key: 6371611
• MDR Text Key: 68980712
• Report Number: MW5068200
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/28/2017
• 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