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

Catalog Number	0134680
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	10/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, about 4 years post implant of composix l/p mesh, patient was diagnosed with hernia recurrence, abdominal pain and underwent revision surgery.Per op notes, "mesh was very protuberant." the adverse reactions section of the instructions-for-use (ifu) supplied with the device list hernia recurrence as a possible complication.This emdr is submitted to represents the mesh - composix l/p (device #2).An additional supplemental emdr was submitted to represent the perfix plug (device #1).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.
Event or Problem Description
Per information provided by the patient's attorney: (b)(6) 2008 - patient was diagnosed with incisional hernia thereby underwent open repair with perfix plug (device #1).Per the operative notes, "incisional hernia was noted and was dissected free.An extra-large perfix plug (device #1) was inserted and sutured." (b)(6) 2011 - patient developed abdominal pain thereby underwent laparoscopic lysis of adhesions, removal of possibly infected mesh and partial omentectomy.Per the operative notes, "adhesions were actually adhered to a piece of mesh (device #1) which seemed to have been bunched up and displaced to the lateral right side.Performed partial omentectomy to free the adhesions from the mesh.There was a possible infection of the mesh.The mesh itself was bunched up and was dissected out." (b)(6) 2011 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with composix l/p mesh (device #2).Per the operative notes, "enterolysis of the omentum and omental attachments to the anterior abdominal wall as well as around the ventral hernia was performed.A composix l/p mesh (device #2) was tacked to the anterior abdominal wall." (b)(6) 2015 and (b)(6) 2015 - during hospital visit patient had abdominal mass and pain.(b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair.Per the operative notes, "the hernia sac was identified which consisted of the previous mesh (device #2) itself.The dissection around the mesh and the fascia was conducted, the mesh was released slightly from the fascia.There was no bowel noted herniating around it but the mesh itself was very protuberant so decided to close the defect over this mesh.The fascia was double breasted using sutures." attorney alleges that the patient had adhesions, mesh migration, mesh shrinkage, pain, hernia recurrence, infections, removal of right ovary because of adhesions and emotional injuries.

• 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: 17461067
• Report Number: 1213643-2023-093142
• Device Sequence Number: 7236774
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: 06/28/2015
• Device Catalogue Number: 0134680
• Device Lot Number: HUUE0357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/04/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 127 KG