MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/13/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by the patient's attorney: on (b)(6) 2008, patient was diagnosed with incisional hernia and underwent laparoscopic repair with implant of composix l/p mesh (device #1).Per operative notes, ¿incisional hernia reinforced using a piece of composix l/p mesh (device #1) and was secured all around the edge using tacker.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of composix kugel mesh (device #2) and explant of composix l/p mesh (device #1).Per operative notes, ¿numerous adhesions along the mesh were dissected.The mesh was dissected off of the muscle layer on both sides of the divided mesh and then the mesh was discarded (device #1).There was a hernia sac below the mesh that was dissected.A piece of composix kugel patch (device #2) was placed into the abdominal wall with propylene side oriented toward the fascia and was tacked.¿ (b)(6) 2014 - patient was diagnosed with pain, erythema, infected abdominal mesh with small bowel fistula thereby underwent removal of composix kugel mesh (device #2).Per operative notes, "there were numerous adhesions to the mesh which were taken down carefully.At the far lateral aspect of the mesh, there was small fistula from the small bowel to the polypropylene aspect to the mesh.This then tracked along the plain between the mesh and the abdominal wall in the area of the containing pus.This portion of bowel and mesh completely removed from the abdomen (device #2).A piece of biological mesh was placed in a retromuscular position.¿ attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, bowel removal, fistulae, infections, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the available information, no conclusion can be made.Per the medical records review, about 1 year post implant of composix l/p mesh, patient was diagnosed with adhesions, hernia recurrence thereby underwent mesh removal.The instructions-for-use supplied with the device identify adhesions, hernia recurrence as possible complications.This emdr represents the composix l/p mesh (device #1).An additional supplemental emdr was submitted to represent the composix kugel mesh (device #2).Note: section a through f - 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.H3 other text : not returned.

• Brand Name: MESH ¿ COMPOSIX L/P
• Common Device Name: SURGICAL 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 Key: 17867414
• Report Number: 1213643-2023-093942
• Device Sequence Number: 7041665
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2013
• Device Catalogue Number: 0134680
• Device Lot Number: HUSC1966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female