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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 Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
As reported, about 4 months post implant of the 3dmax mesh fixated by the capsure straight device, the patient experienced pain and infection. The patient was prescribed oral antibiotics and is responding well. Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms. Infection is a known inherent risk of surgery. The warnings section of the instruction for use (ifu) supplied with this device states, "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " to date, this is the only reported complaint for this manufacturing lot. This mdr represents the bard/davol 3dmax mesh (device #1). An additional mdr was submitted to represent the bard/davol capsure straight (device #2). Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
It was reported that, during a laparoscopic procedure on (b)(6) 2020, the patient was implanted with a bard/davol 3dmax mesh fixated by a bard/davol capsure straight fixation device. The patient was fine after the surgery. One week post-implant, the patient had complaints of pain and was prescribed analgesics by the surgeon. The patient returned on (b)(6) 2021 with pain and swelling; the surgeon suspected infection which was confirmed by an ultra-sonogram. The patient was prescribed an oral antibiotic augmentin 650mg twice a day and is responding well. As reported, mesh removal may or may not be required based on the patient's response.
 
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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 Key11222253
MDR Text Key241237254
Report Number1213643-2021-20006
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0115321
Device Lot NumberHUDT2112
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 Received01/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/25/2021 Patient Sequence Number: 1
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