MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123114
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a ventral incisional hernia repair procedure on (b)(6) 2014, a bard/davol composix e/x mesh was implanted.It was reported that on (b)(6) 2021, the patient underwent another surgery for colorectal cancer, during which it was noted that the mesh (eptfe side) had fibrous adhesions with the intestinal tract.As reported, there was no extreme bending of the mesh, the polypropylene side was not exposed to the intestinal tract side and lysis of adhesions was performed for about 2 hours.As reported, after making a midline incision in the mesh and treating colorectal cancer, the mesh was brought close together and closed with a non-absorbent thread, and a non-bard/davol adhesion-preventing material was attached to complete the procedure.The patient did not experience any pain or other symptoms due to the adhesions.Postoperatively the patient is doing good without any health damage.
Additional Manufacturer Narrative
As reported, about 7.5 years post-implant of the composix e/x mesh, while undergoing an additional surgery unrelated to the hernia repair, mesh adhesions were noted to the intestinal tract.The adhesions were lysed and an adhesion barrier was placed, as reported the patient is currently in good health.Based on the information provided, no conclusion can be made.Adhesions are a known inherent risk of hernia repair surgery and are listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Not returned - remains implanted.
Additional Manufacturer Narrative
As reported, about 7.5 years post-implant of the composix e/x mesh, while undergoing an additional surgery unrelated to the hernia repair, mesh adhesions were noted to the intestinal tract.The adhesions were lysed and an adhesion barrier was placed, as reported the patient is currently in good health.Based on the information provided, no conclusion can be made.Adhesions are a known inherent risk of hernia repair surgery and are listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the corrected patient information.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 - remains implanted.
Event or Problem Description
As reported, during a ventral incisional hernia repair procedure on (b)(6) 2014, a bard/davol composix e/x mesh was implanted.It was reported that on (b)(6) 2021, the patient underwent another surgery for colorectal cancer, during which it was noted that the mesh (eptfe side) had fibrous adhesions with the intestinal tract.As reported, there was no extreme bending of the mesh, the polypropylene side was not exposed to the intestinal tract side and lysis of adhesions was performed for about 2 hours.As reported, after making a midline incision in the mesh and treating colorectal cancer, the mesh was brought close together and closed with a non-absorbent thread, and a non-bard/davol adhesion-preventing material was attached to complete the procedure.The patient did not experience any pain or other symptoms due to the adhesions.Postoperatively the patient is doing good without any health damage.

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 13097122
• Report Number: 1213643-2021-20482
• Device Sequence Number: 2047672
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Catalogue Number: 0123114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG