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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010303
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
The subject product is being returned for evaluation; however, at this time has not been received. Based on the available information, we are unable to determine a definitive root cause for the reported event. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) released for distribution in august 2019. If/when the sample is received and evaluated, a supplemental mdr will be submitted. Sample not returned.
 
Event Description
As reported, during an open laparoscopic procedure on (b)(6) 2020, while opening the bd/davol ventralex mesh, the nursing staff noticed that the sterile packaging was damaged. The device was not used, another ventralex mesh was used to complete the procedure as a result there was a delay in completing the procedure. The issue was identified prior to use and there was no reported patient injury.
 
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Brand NameMESH VENTRALEX
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 Key11097704
MDR Text Key224790228
Report Number1213643-2020-20088
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0010303
Device Lot NumberHUDS2315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2019
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: 12/30/2020 Patient Sequence Number: 1
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