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

Catalog Number UNKAA013

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Hernia (2240)

Event Date 02/14/2011

Event Type  Injury  

Manufacturer Narrative

This emdr represents the collamend mesh (device #2).An additional emdr was submitted for the composix e/x mesh (device #1).No conclusions can be made.Based on the information provided in the medical records, the patient with a complex repair procedure which included the implant of the collemend (device 2) was diagnosed with a post-operative mrsa infection and anterior abdominal wound cellulitis and treated with a wound vac and assisted closure.Approximately, a month later, the patient was treated for a recurrent hernia during which it was noted that the prolene sutures holding the collemend (device 2) had broken.At this point, the collemend was re-secured and both previously implanted mesh devices remained implanted.Approximately, 3 years later the patient was diagnosed with an incision hernia, and during treatment for this hernia both previously implant mesh (device 1 and 2) were explanted and noted to be infected.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists hernia recurrence as a possible complications.In regards to infection, is a known possible adverse reaction listed in the ifu.The warning section of the ifu states ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ the information provided by bd 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 bd.Not returned.

Event Description

Per medical records: (b)(6) 2006 - patient was diagnosed with incarcerated ventral hernia and scheduled for laparoscopic repair.As per operative notes," i went ahead and reduced the hernia.Once this was reduced, we went ahead and placed a dual mesh (composix e/x, device #1) into the abdomen." (b)(6) 2008 - patient was diagnosed with large recurrent incisional hernia and underwent open repair with implant of collamend mesh (device #2).As per operative notes, ¿mesh (composix e/x, device #1) had torn out from its lateral attachments.I went ahead and took down multiple adhesions within the sac.I went ahead and tacked the mesh (composix e/x) placed previously.I now went ahead and inserted a collamend mesh (device #2)." (b)(6) 2008 - patient was diagnosed with partial dehiscence, staphylococcus aureus (mrsa), anterior abdominal wound cellulitis; underwent wound debridement with placement of a wound vacuum assisted closure (vac).(b)(6) 2008 - patient was diagnosed with recurrent ventral hernia and underwent laparoscopic-converted to open repair.As per operative notes, ¿she had a previously placed mesh (device #2) over this and¿the 0 prolene sutures had broken in the middle and had become unfurled.I went ahead, pulled the mesh to the left upper quadrant side and.Placed the mesh back in position." (b)(6) 2008 - patient underwent abdominal wall abscess removal.As per operative notes, ¿we opened up the cavity with finger dissection.There was some foreign body material, some suture material, at the base of this¿this was taken out¿placed the wound vac into the abdominal wall abscess location." (b)(6) 2011 - patient was diagnosed with ventral incisional hernia.As per operative notes, ¿all of the different pieces of mesh (device #1)(device #2) and multiple kinds of suture material and titanium tacks were all removed by a combination of blunt and sharp dissection." a non-bard/davol mesh was placed after taking out the infected meshes.

• 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: 16146292
• MDR Text Key: 307171958
• Report Number: 1213643-2023-090127
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 124 KG