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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 0115311
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

As reported the patient was treated with a 3dmax mesh and is alleged to have experienced post surgical pain. It was alleged that the pain led to a second surgery (on the opposite side) and mobility issues. Contact information was not provided; therefore requests for clarity cannot be made. At this time it is unclear if there was another herniation that required treatment, or if the post surgical pain has resolved. There is no known malfunction of the device as reported and due to the limited information provided; no conclusion can be made as to the connection between the implanted bard device and the reported need for additional surgery. Should additional information be obtained, a supplemental 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.

 
Event Description

The following was reported per maude event (mw5072832): "hernia repair pain after surgery only to have the opposite side done to treat pain and mobility issues. ".

 
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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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7051003
MDR Text Key92730529
Report Number1213643-2017-00900
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115311
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 Received10/30/2017
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: 11/21/2017 Patient Sequence Number: 1
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