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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 0112650
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Unspecified Infection (1930); Hernia (2240); Disability (2371)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, adhesions, inflammation, hernia recurrence and surgical intervention. The instructions-for-use supplied with the device lists adhesions, inflammation and recurrence as possible complications. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. In regards to the infection, the warning section of the ifu states: "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " this emdr represents the bard/davol marlex (bard flat mesh) (device #2). An additional emdr was submitted to represent the bard/davol perfix plug (device #1). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that on or about (b)(6) 2008, the patient was implanted with a non-bard/davol mesh to repair a ventral hernia. It is alleged that on or about (b)(6) 2010 the patient underwent revision of the non-bard/davol mesh to repair the mesh and a second non-bard/davol mesh was implanted. It is also alleged that on or about (b)(6) 2015, the patient underwent surgery for hernia repair. A bard/davol perfix plug was implanted during the repair. It is alleged that the patient underwent revision surgery on or about (b)(6) 2015. A bard/davol marlex mesh (bard flat mesh) was implanted to repair a hernia. The patient underwent removal surgery on or about (b)(6) 2018. It is alleged that the patient experienced and/or continues to experience severe and chronic pain, recurrence, adhesions, mesh contraction, fluid collection, mesh migration/detachment, fractured xiphoid process, bowel resection, infection, surgery to remove mesh, and abdominal wall reconstruction. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is further alleged that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key11381743
MDR Text Key233738961
Report Number1213643-2021-01316
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
Type of Report Initial
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2019
Device Catalogue Number0112650
Device LOT NumberHUYD0163
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2014
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: 02/25/2021 Patient Sequence Number: 1
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