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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Discomfort (2330)
Event Date 12/01/2021
Event Type  Injury  
Event Description
As reported, during a gastrointestinal hepatobiliary surgery on (b)(6) 2021, a bard/davol 3dmax mesh was implanted. Following surgery, the patient had foreign body sensation and discomfort and analgesics were given immediately to relieve the discomfort.
 
Manufacturer Narrative
As reported, post-implant of the 3dmax mesh, the patient experienced foreign body sensation, discomfort and was given analgesics for relief. Post-op discomfort is a known inherent outcome of any surgery. Based on the information provided, no conclusion can be made. Review of manufacturing records confirms the product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in nov, 2020. Not returned - remains implanted.
 
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Brand Name3DMAX
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 Key13097058
MDR Text Key282958364
Report Number1213643-2021-20481
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0115321
Device Lot NumberHUEX2434
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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: 12/28/2021 Patient Sequence Number: 1
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