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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED SURGICAL MESH Back to Search Results
Catalog Number 0113710
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 12/09/2015
Event Type  Injury  
Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The patient's attorney did not allege a specific device failure and no medical records have been provided. Based on the limited information provided at this time, no conclusions can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be obtained, a supplemental emdr will be submitted. This emdr represents the bard/davol "marlex" mesh and additional emdr was submitted to document information related to the bard/davol perfix plug. 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 to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent surgery to repair a right inguinal hernia. As reported, a bard/davol "marlex" mesh and a bard/davol perfix plug were implanted to repair the hernia defect. On (b)(6) 2015 - the patient underwent an additional surgery to repair a recurrent right inguinal hernia. The attorney for the patient alleges that the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the defective mesh products.

 
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Brand NameBARD MESH PRE-SHAPED
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 Key7139364
MDR Text Key95533833
Report Number1213643-2017-01086
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPREAMENDMENT
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 12/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2019
Device Catalogue Number0113710
Device LOT NumberHUYI1990
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 Received12/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2014
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: 12/21/2017 Patient Sequence Number: 1
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