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

Catalog Number	0123680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2002 ¿ patient was diagnosed with incisional hernia thereby underwent repair with implant of unknown mesh.(note: there is no operative notes provided for this procedure in medical records).(b)(6) 2003 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with implant of two composix e/x (device 1 and 2).Per operative notes, ¿dense scar tissue was noted.Three large incisional hernias with encased bowel were noted and dissected.Adhesions were lysed.Two separate meshes (device 1 and 2) was placed covering the entire defect and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent incarcerated incisional hernia and enterocutaneous fistula and infected mesh (device 1 and 2) thereby underwent removal of previously placed meshes (device 1 and 2).Per operative notes, ¿intraabdominal adhesions of omentum, small bowel, colon and hard central fistula cluster were dissected.The infected meshes (device 1 and 2) were removed and lower abdominal hernia sac was dissected free of its wall.Thick scar tissue and recurrent ventral incisional hernia was closed with sutures.¿.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This emdr represents the bard mesh - composix e/x (device 2).An additional supplemental emdr was submitted to represent the bard mesh - composix e/x (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.

• Brand Name: MESH - COMPOSIX 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: 22903002
• Report Number: 1213643-2025-00794
• Device Sequence Number: 8000999
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(10)43HND310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 0123680
• Device Lot Number: 43HND310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 67 YR
• Patient Sex: Female