MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COLLAMEND; PORCINE SURGICAL MESH

Catalog Number 1175102

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Adhesion(s) (1695); Hernia (2240)

Event Date 03/19/2010

Event Type  Injury  

Manufacturer Narrative

Based on the additional information received, no conclusions can be made.Per medical record review, this patient with a history of hernia repairs had recurrent hernia and was repaired using a collamend mesh.Over 2 years later, the patient was diagnosed with multiple recurrent incisional ventral hernias and subsequently underwent mesh explant.The instructions-for-use supplied with the device lists hernia recurrence and adhesion as possible complications.This emdr represents the collamend mesh (device #2).A supplemental emdr was submitted for the composix kugel (device #1).Not returned.

Event Description

Per information provided by patient's attorney: (b)(6) 2007 - patient was diagnosed with umbilical and incisional hernia and underwent repair with bard composix kugel mesh.Per the operative notes, "the hernia sac was excised circumferentially.A piece of bard composix mesh (device #1) was inserted and sutured." (b)(6) 2008 - patient was diagnosed with recurrent ventral hernia and underwent laparoscopic repair for removal of old mesh and placement of new mesh.Per operative notes, "a fair amount of omentum anterior to old mesh was taken down.Given the amount of cicatrix formation in this region, the mesh was removed.The mesh itself was excised because the hernia was located above the prior site of mesh.¿ the hernia was repaired using two synthetic mesh overlapping each other.(b)(6) 2008- patient was diagnosed with abdominal wound abscess and underwent incision and drainage for abdominal wound abscess.(b)(6) 2008 - patient had redness of wound with drainage, recurrent incisional hernia with abscess and underwent open repair with collamend mesh along with excision of old mesh.Per operative notes ¿the wound was hemostatic.Old mesh (synthetic mesh) was removed.There was noted to be an incisional hernia at the inferior portion of the prior mesh placement.A collamend mesh (device #2) was placed and sutured¿.(b)(6) 2010 - patient had recurrent incisional ventral hernias and extensive adhesiolysis and underwent laparoscopic repair with sepramesh ip (device #3).Per operative notes ¿there were multiple adhesions.The mesh showed evidence of curling away from the superior portion of the defects.The old collamend mesh was removed completely.A piece of sepramesh ip (device #3) was cut to fit overlaying small defects and sutured.¿ attorney alleges that the patient experienced abscesses, adhesions, emotional injuries without treatment, infections, mesh migration, pain, recurrence and others like abdominal wound abscess.

• Brand Name: COLLAMEND
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. - 1223089; 160 new boston street; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 17001208
• MDR Text Key: 315910387
• Report Number: 1213643-2023-092097
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1175102
• Device Lot Number: DARJ0666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 103 KG