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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117310
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, a piece of the 3dmax light mesh fell into the patient's abdomen, during insertion through the trocar. The mesh sample was not returned, as such we are unable to determine the cause of the reported issue. Based on the available information and not having the sample to evaluate, no conclusion can be made. Review of manufacturing records confirms the product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020. The instructions for use supplied with the device states "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force. " if additional information/sample is provided, a supplemental mdr will be submitted.
 
Event Description
As reported, during a procedure on (b)(6) 2021, during insertion of a bard/davol 3dmax light mesh through a trocar, a piece of mesh fell into the patient's abdomen. It is reported that it is unclear to the user whether the piece of mesh found, tore off the mesh during insertion, or if it was on the device and fell off during insertion. As reported, the mesh piece and device were removed from the patient. There was no reported patient injury.
 
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Brand Name3DMAX LIGHT
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 Key12274761
MDR Text Key264977470
Report Number1213643-2021-20220
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091659
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 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117310
Device Lot NumberHUEX0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2020
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: 08/04/2021 Patient Sequence Number: 1
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