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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112660
Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problems Urticaria (2278); Reaction (2414)
Event Date 06/10/2017
Event Type  Injury  
Manufacturer Narrative

No conclusion can be made. Based on the information provided the mesh was not involved in the patient's wound dehiscence and non healing wound issues per physician progress notes. At this time, we are unable to determine a correlation between the patient's reported postoperative symptoms (hives) and the davol mesh product used to treat the patient. A mesh sample has been provided to the patient's allergist for reactivity testing. The testing has not been completed to date. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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 to davol: on (b)(6) 2017 - the patient underwent the repair of a recurrent incisional hernia. During this procedure an unknown mesh was removed and the hernia was repaired with a bard/davol flat mesh. On (b)(6) 2017 - the patient had wound dehiscence and underwent an additional surgical procedure which involved removal of abdominal soft tissue that was not healing properly. Patient's wound was then treated routinely at a wound clinic. As reported, the progress notes indicated that the "mesh was not involved or removed. " on (b)(6) 2017 - the patient presented to the surgeons office with complaints of hives all over and felt it was related to the flat mesh implant. The patient has seen multiple allergists and currently her allergist agreed with performing a reactivity test with the mesh.

 
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Brand NameBARD FLAT MESH
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 Key7864152
MDR Text Key119814466
Report Number1213643-2018-03095
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2021
Device Catalogue Number0112660
Device LOT NumberHUAV0186
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/25/2016
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: 09/11/2018 Patient Sequence Number: 1
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