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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
Model Number 0115311
Device Problems Defective Device (2588); Folded (2630)
Patient Problems Pain (1994); Disability (2371)
Event Date 08/31/2015
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided indicated that the patient underwent an additional surgery to "repair the hernia defect and remove it. As medical records were not provided and the description does not clearly define was "remove it" is being referred to we have not identified this to be a reported device explant at this time. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications. If additional event and/or evaluation information is obtained, a follow up mdr 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 to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent surgery for repair of a left inguinal hernia with implant of a 3dmax mesh. On (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it. During the surgery, the patient noted that "the mesh was clamshelled along the lower third and it was also folded medially. " the patient was injured severely and permanently. The attorney alleges the patient has suffered and will continue to suffer physical pain.
 
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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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6873435
MDR Text Key86558331
Report Number1213643-2017-00603
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 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2020
Device Model Number0115311
Device Catalogue Number0115311
Device Lot NumberHUZB0180
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 Received08/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2015
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: 09/18/2017 Patient Sequence Number: 1
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