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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 0115311
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Dysuria (2684); Constipation (3274)
Event Date 06/12/2018
Event Type  Injury  
Manufacturer Narrative

As reported, the patient experienced difficulty in passing urine, constipation and pain in the bowel area post 3dmax mesh implant. The implanting surgeon does not believe the patient's symptoms to be associated with hernia repair surgery. The patient has been diagnosed by a urologist with chronic pelvic pain syndrome. Based on the information provided, no conclusion can be made as to the degree to which the implanted mesh, may be causing or contributing the patient¿s reported symptoms. To date, this is the only reported complaint for this manufacturing lot. This mdr represents the bard/davol 3dmax mesh on the left side (device #1). An additional mdr was submitted to represent the bard/davol 3dmax mesh on the right side (device #2). Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.

 
Event Description

As reported per the surgeon: on (b)(6) 2018 - the patient was implanted with two 3dmax meshes bilaterally (right and left side) in a laparoscopic inguinal hernia repair procedure. On (b)(6) 2018 - the patient was discharged. After surgery, the patient had complaints of difficulty in passing urine and constipation. The surgeon informed that the problems were not related to the mesh. On (b)(6) 2018, (b)(6) 2018 and (b)(6) 2018 - the patient had follow-up visits due to pain in the bowel area near mesh implant, discomfort in lower abdomen and incomplete sense of evacuation. As reported, the patient has consulted with urologists and has been diagnosed with chronic pelvic pain syndrome (cpps) with no relation to the lap procedure. The patient is doing well with no medical or surgical intervention required.

 
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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 Key11253176
MDR Text Key229441752
Report Number1213643-2021-20013
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115311
Device LOT NumberHUBS0624
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 Received01/05/2021
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: 01/29/2021 Patient Sequence Number: 1
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