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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 Problem Folded (2630)
Patient Problems Nerve Damage (1979); Pain (1994); Disability (2371)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative

There is no connection that can be made at this time between the reported postoperative complication and any problem / defect with the davol device alleged to have been used to treat the patient. As reported eleven years post implant a ct scan found that the mesh had folded and the patient underwent a revision procedure. Additional information has been requested, however at this time the information provided is limited to the maude event report. Based on the information provided to date, no conclusion can be made. Without a lot number a review of the manufacturing records is not possible. 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 was reported via maude event report (mw5074955): "i have really bad pains in the left inguinal region where i had prior surgery for an inguinal hernia. Seen surgeon who ordered cat scan. Found out that hernia mesh was folded. Had surgery to remove it but a piece was left on the inguinal ligament. I have ilioinguinal and iliohypogastric neuroglia. I have been prescribed a walking cane to help me walk. I am in pain 24/7 and the pain is worse in the evening hours. I am still going through the diagnosis stages, so i may discover more damage. ".

 
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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 Key7359187
MDR Text Key103133089
Report Number1213643-2018-00707
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK953577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received02/27/2018
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: 03/21/2018 Patient Sequence Number: 1
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