• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX SURGICAL MESH Back to Search Results
Catalog Number UNKAA018
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Seroma (2069); Deformity/ Disfigurement (2360); Disability (2371)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcomes associated with the hernia mesh used to treat the patient including seroma, migration, pain, surgical intervention for mesh removal. No lot number has been provided; therefore, a review of the manufacturing records is not possible. The instructions-for-use supplied with the device lists seroma as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that on or about (b)(6) 2010, the patient underwent ventral hernia repair and an unspecified bard/davol composix hernia mesh was implanted during this repair to cover six inches of a ventral hernia. On or about (b)(6) 2010, the patient experienced severe pain, the day after the hernia mesh was implanted. After a review of a cat scan, the surgeon noted that the mesh was loose and a seroma, a pocket of clear serous fluid composed of blood plasma, had developed. On or about (b)(6) 2010, the surgeon performed another cat scan and noted that the mesh was loose and "alive in there. " on or about 2011, the patient continued to experience severe pain. The surgeon reviewed the cat scan and noted that the mesh had migrated over the patient's colon and was too dangerous to operate. On or about 2014, the patient was referred to another surgeon who stated that it would not be operated since it was too dangerous and noted that the mesh was "floppy" and on the colon. The surgeon performed laparoscopic surgery as a temporary fix, to move the mesh away from the colon and noted that there was excess mesh due to its stretching. On or about (b)(6) 2018, the patient continued to experience severe pain and met with the primary care physician. The physician referred the patient to another surgeon who specializes in the removal of these hernia meshes. On or about (b)(6) 2018, the patient underwent removal of the defective composix hernia mesh and a total abdominal reconstruction. Upon visualizing the composix hernia mesh, the surgeon noted "the mesh was the size of a soccer ball. " due to the size of the mesh removed, the client's skin had been stretched and the excess skin on the stomach hung down over the perineal area and can only be repaired by a plastic surgeon. It is alleged that the patient suffered severe pain from (b)(6) 2010 to (b)(6) 2018 and has disfigurement that can only be repaired by a plastic surgeon. 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 also alleged that the patient experienced emotional distress and the device was defective.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH - COMPOSIX
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 Key10922921
MDR Text Key218914058
Report Number1213643-2020-10761
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK971745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
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: 11/30/2020 Patient Sequence Number: 1
-
-