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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, 2 years post-implant of the bard/davol ventralight st mesh, the patient underwent a surgery for reasons unrelated to the mesh during which a small hole was observed in the mesh. As reported, the surgeon is an experienced user and faced no issues during mesh implant. Intra-operative photos were provided. Review of images provided of the implant identify an area in the center with an apparent defect. Based on evaluation of the image and information provided, the cause of the defect cannot be determined; as such, no conclusion can be made. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Note, the date of implant is considered to be a best estimate as (b)(6) 2021 based on the reported event. Should additional information be provided, a supplemental mdr will be submitted. Not returned. Remains implanted.
 
Event Description
As reported, the surgeon implanted a bard/davol ventralight st mesh using the echo positioning system in 2019. The mesh was intact and was placed successfully. As reported, the patient underwent 2 revision surgeries (2020 & 2021) post-implant for reasons unrelated to the mesh. During the last surgery on (b)(6) 2021, the surgeon noticed that there was a hole in the middle of the mesh. The doctor reported that the patient was fine, without infection or any kind of complaint that could lead to some kind of concern with implant.
 
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Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key12452196
MDR Text Key270773847
Report Number1213643-2021-20320
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Catalogue Number5955600
Device Lot NumberHUDT0098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
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