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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number 5959812
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Fatigue (1849); Pain (1994); Injury (2348)
Event Date 03/15/2017
Event Type  Injury  
Manufacturer Narrative
Based on the limited information provided in the legal claim we are unable to determine to what extent, if any, the sepramesh ip may have caused or contributed to the events as alleged. Additional information has been requested. The surgery dates are estimates as the exact dates for the procedures were not provided. Should additional information be obtained, a supplemental emdr will be submitted. Note: the legal claim was not immediately forwarded to field assurance for processing. As such this report is being filed beyond the initial 30-day notification period. 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. Not returned.
 
Event Description
The following was alleged by the patient's attorney. In (b)(6) 2011 the patient was implanted with a davol sepramesh ip. As alleged the mesh failed and in october, 2013 the patient underwent surgery to remove part of the sepramesh ip. As reported in (b)(6) 2017 the patient underwent an additional procedure to remove the remainder of the sepramesh ip. It is alleged that during both of the subsequent surgeries the patient was implanted with unspecified mesh. The patient's attorney alleges that the patient suffered chronic pain and fatigue / lethargy and general injuries to her abdomen as a result of the defective mesh. It is alleged that the patient's symptoms of chronic pain and fatigue / lethargy have continued throughout and following the surgery in (b)(6) 2017.
 
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Brand NameSEPRAMESH IP
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 Key7568911
MDR Text Key110067913
Report Number1213643-2018-01806
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K063739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2013
Device Catalogue Number5959812
Device Lot NumberHUVF0220
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 Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2011
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: 06/05/2018 Patient Sequence Number: 1
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