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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 Pain (1994); Hernia (2240); Disability (2371)
Event Date 03/23/2012
Event Type  Injury  
Manufacturer Narrative
To date limited information has been provided. Based on the information available at this time, no conclusions can be made as to what degree, if any the 3dmax caused or contributed to the alleged event. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication. Should additional information be provided a supplemental emdr will be submitted. 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 information was reported to davol by the patient's attorney: on (b)(6) 2006: the patient underwent surgery for the repair of a right inguinal hernia and umbilical hernia. As reported, a bard/davol 3dmax was implanted to repair the (inguinal) hernia defect. On (b)(6) 2012: the patient underwent an additional surgery to repair a recurrent hernia. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective 3dmax.
 
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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 Key7143110
MDR Text Key95654009
Report Number1213643-2017-01104
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953577
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 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
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 Received12/05/2017
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: 12/22/2017 Patient Sequence Number: 1
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