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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Torn Material (3024)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the patient is experiencing bilateral pain, which is more prominent on the right side. Also reported is that the patient feels that the mesh has torn. As reported the patient has been seen by his md on multiple occasions who has not found anything wrong with the mesh. At this time, no conclusion can be made as to the degree to which the mesh implants may be causing or contributing to the reported patient outcome. Should additional information be provided, a supplemental mdr will be submitted. This mdr represents the bard 3dmax mesh implanted on the patient's right side. An additional mdr has been submitted to document the information associated the bard 3dmax mesh implanted on the patient's left side. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Device remains implanted.
 
Event Description
The following was reported to davol: in 2011 the patient underwent a bilateral inguinal hernia repair and was implanted with two bard/davol 3dmax mesh devices. Following the repair the patient began to have some pain on the right side. He saw his md who did not note any problem with the mesh. The md indicated the issue was due to probable scar tissue as this was not the first surgical procedure to have been performed in this area. The patient then reports he had a "coughing fit" in which he thinks he felt the mesh rip inside his right groin. Following that he states he has the same feeling when he lifts weights at the gym, "it feels as if the mesh is ripping. " the patient returned to his md, who again did not find anything wrong with the mesh and advised that a reoperation or removal of the mesh would not be beneficial as it may do more harm than good. As reported the patient has pain with bowel movements and is expecting to undergo additional surgical intervention in the future. Regarding the left sided repair it is reported that the patient is having some pain on the left side as well; however, the pain is reported as more prominent on the right side.
 
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Brand Name3DMAX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6489327
MDR Text Key72658380
Report Number1213643-2017-00238
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030765
UDI-Public(01)00801741030765(17)150728(10)HUUF2341
Combination Product (y/n)N
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2015
Device Catalogue Number0115321
Device Lot NumberHUUF2341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2010
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: 04/13/2017 Patient Sequence Number: 1
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