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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 2 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
Catalog Number 5990015
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, upon implant a ¿piece of plastic¿ , was noted to be sticking to the surface of the ventralight st mesh. The plastic piece was removed from the mesh and provided for evaluation. Visual examination of the received ¿plastic piece¿ confirmed it is not a component of the device or of the device¿s packing. In addition, the received piece of plastic did not contain any markings that would help to identify its possible source. Based on the sample evaluation and the investigation performed, the source of the plastic material could not be determined. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of 90 units released for distribution in december, 2020 if further information is obtained that indicates a possible source of the ¿plastic piece¿ a semdr will be submitted to document these findings. Sample evaluated.
 
Event Description
As reported, on (b)(6) 2021 during an umbilical hernia repair procedure, a bard/davol ventralight st w/echo 2 positioning system (ps) was used. After successfully fixating the mesh, the ps frame was removed and the surgeon noted a piece of plastic sticking to the mesh surface. As reported, the surgeon removed the piece and placed into a specimen cup. The mesh was successfully implanted. There was no reported patient injury.
 
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Brand NameVENTRALIGHT ST W/ ECHO 2
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 Key11708743
MDR Text Key255838650
Report Number1213643-2021-20089
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Catalogue Number5990015
Device Lot NumberHUEX1721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2020
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: 04/22/2021 Patient Sequence Number: 1
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