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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 0115321
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

At this time no conclusion can be made. As reported the cause of the patient's symptoms have not been determined. The patient was examined by several doctors. At this time, there is no identification that the 3dmax mesh implants are causing the patient's symptoms. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in january, 2013. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Note the date of implant is estimated as the actual date was not provided. Should additional information be obtained, a supplemental emdr will be submitted. This emdr is associated to the right sided repair, an additional emdr was submitted with information associated to the left sided repair. 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

It was reported that in 2013 the patient underwent bilateral inguinal hernia repair and was implanted with one large right and one large left 3dmax mesh. The patient reports experiencing chronic uti's, constipation, and pain since the implant of the mesh. As reported the patient has been evaluated by several urologists who are unable to determine the cause of his symptoms. The patient is unable to follow up with the implanting surgeon as he has since retired. The patient is seeking a new surgeon, as he would like to have the mesh removed.

 
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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 Key7925379
MDR Text Key122303665
Report Number1213643-2018-03369
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2018
Device Catalogue Number0115321
Device LOT NumberHUWL1334
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/02/2018 Patient Sequence Number: 1
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