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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number UNKAA002
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Dysuria (2684)
Event Date 10/27/2017
Event Type  Injury  
Manufacturer Narrative

While we do not know the anatomical placement of the ethicon mesh vs the davol mesh, based on the information as reported there does not appear to be an adverse event allegation involving the davol 3dmax light mesh. The complainant clearly states concern for having "the same mesh again the 3rd time" and according to the event as reported the patient has two previously implanted ethicon mesh and only one davol mesh. The date of event is documented on the maude event report as the date of implant of the davol mesh. The maude event report did not include contact information, therefore we are unable to request additional information. At this time, no conclusion can made at this time. A lot number was not provided, therefore a review of the manufacturing records is not possible. Should additional information be obtained, 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. Remains implanted.

 
Event Description

The following was reported via maude event report (mw5077143): on (b)(6) 2015 - patient underwent hernia repair using a non bard/davol ultrapro (ethicon) mesh. The mesh failed and the patient had severe pain, difficulty urinating and difficulty walking due to the pain. On (b)(6) 2017- patient underwent second surgery with explant of the previous (ethicon) mesh and implant of a new non bard/davol ultrapro (ethicon) mesh. On (b)(6) 2017 - patient underwent a hernia repair using the bard/davol 3dmax light. "had an ethicon ultrapro hernia mesh put in on (b)(6) 2015 mesh failed. Had severe pain and problems urinating and discomfort problems walking due to the pain. Had 2nd surgery (implant/explant ethicon mesh) done same doctor repaired mesh on (b)(6) 2017. Now i am having the same painful problems and may need a 3rd surgery. " "afraid to have the same mesh again the 3rd time!".

 
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Brand Name3DMAX LIGHT
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 Key7709758
MDR Text Key114674776
Report Number1213643-2018-02459
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
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: 07/23/2018 Patient Sequence Number: 1
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