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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 UNKAA001
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Neuropathy (1983); Hernia (2240); Disability (2371)
Event Date 06/15/2017
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the bard/davol 3dmax device may have caused or contributed to the events as alleged by the patient¿s attorney. The information provided alleges the patient underwent an additional "repair surgery of hernia and hernia mesh" with partial explant of the bard/davol 3dmax. No medical records have been provided; however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted. Note: 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. Not returned.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery with an implant of a bard/davol 3dmax mesh for the repair of a right inguinal hernia. It is alleged that in early 2017, the patient started experiencing pain radiating from his abdomen and neuropathy. As reported, the patient's physicians elected for a repair surgery of hernia and hernia mesh. It is alleged that in 2017 the patient underwent repair surgery. As reported, upon entering the abdominal cavity, the surgeon noted that the bard 3dmax mesh has failed and removed part of the mesh. As alleged, as a result of having the "product" implanted in him, the patient has suffered pain, neuropathy, and experienced significant physical pain and suffering. It is alleged the bard/davol 3dmax mesh is defective.
 
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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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7609194
MDR Text Key111307645
Report Number1213643-2018-01998
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA001
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 Received06/04/2018
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: 06/18/2018 Patient Sequence Number: 1
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