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

Catalog Number	0134450
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Necrosis (1971); Hernia (2240)
Date of Event	07/30/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per provided medical records: on (b)(6) 2007 - patient was diagnosed with incarcerated recurrent ventral hernia and was scheduled for repair.Per operative notes "he was noted to have a large incarcerated mesh (no product identifiers provided) in the abdominal wall subcutaneous space.Then placed a piece of bard composix lp mesh (device #1) of circular shape measuring 11.4 cm in diameter into the preperitoneal location".On (b)(6) 2012 - patient was diagnosed with recurrent incarcerated incisional hernia and underwent recurrent incarcerated incisional hernia repair.Per operative notes "the hernia was identified then lysed adhesions on the intraperitoneal area to gain complete access.Inferiorly, i could palpate the previous mesh (device #1) repair.This appeared to recover just superior to the mesh.I therefore cleared out an area and took a piece of mesh 8 cm circle ventralex st (device #2) type.This was placed in the intraperitoneal space, oriented appropriately." on (b)(6) 2014 - patient was diagnosed with recurrent ventral incisional hernia, intraabdominal adhesions, underwent laparoscopic recurrent ventral incisional hernia repair.Per operative notes "upper midline adhesions loosely attached to loops of small bowel, all of which were lysed.A 2 cm empty recurrent ventral incisional hernia in the center in between 2 incorporated sheets of old mesh (device #1, device #2) was noted, with a prominent ridge of what appeared to be folded mesh near the ventral incisional hernia.Additionally, an empty left inguinal hernia identified laparoscopically.A 7 to 8 cm hernia sac was identified, freed from adherent tissue, and inverted into the intraabdominal cavity, with placement of an extra large perfix plug (device #3) under the fascia and into the hernia sac with coverage of the hernia defect".
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Medical records indicate the patient was treated for hernia recurrence and adhesion 4.5 years post implant of the composix lp mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the composix l/p (device #1).An additional supplemental emdr was submitted to represents the ventralex st (device #2).There is no indication of an adverse event associated with the device #3 (perfix plug).Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

• 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: 16113899
• Report Number: 1213643-2022-097649
• Device Sequence Number: 5754224
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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: 06/28/2012
• Device Catalogue Number: 0134450
• Device Lot Number: DARF0013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/06/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 118 KG