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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUBSIDIARY OF CR BARD INC. VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
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DAVOL INC., SUBSIDIARY OF CR BARD INC. VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM Back to Search Results
Model Number 5955450
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/12/2015
Event Type  Injury  
Event Description
This case involves a (b)(6) female with history of periumbilical hernia and arthritis.She presented to ambulatory surgery on (b)(6) 2015 for a scheduled laparoscopic umbilical hernia repair with mesh.She had the procedure and was transferred to the post anesthesia unit.It was realized that the mesh positioning system (scaffold) was not removed.The surgeon spoke with the patient and the patient's husband.The patient returned to the operating room for extraction of the foreign object.The patient was discharged home later that day.
 
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Brand Name
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
Type of Device
MESH
Manufacturer (Section D)
DAVOL INC., SUBSIDIARY OF CR BARD INC.
100 crossings blvd
warwick RI 02886
MDR Report Key5416179
MDR Text Key37721166
Report Number5416179
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2017
Device Model Number5955450
Device Lot NumberHUZG1334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/16/2015
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2015
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient Weight54
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