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

Catalog Number	0123460
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	03/05/2008
Type of Reportable Event	Serious Injury
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 mdr represents the bard/davol composix e/x (device 2).An additional supplemental emdr was submitted to represent the bard/davol 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.
Event or Problem Description
Per information provided: (b)(6) 2024 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of composix e/x mesh (device 1 and 2).Per op notes, ¿the hernia was identified in the epigastric area and the omentum was partially reduced.Adhesions between the small bowel and hernia sac were lysed.Small bowel adherent to the anterior abdominal wall were lysed.A composix e/x mesh (device 1) was placed along the anterior abdominal wall and secured with tacker.A composix e/x mesh (device 2) was placed into the peritoneal cavity in the identical configuration and secured to the anterior abdominal wall with tacker.¿ (b)(6) 2008 - patient was diagnosed with infected mesh and recurrent incisional hernia thereby underwent open repair with excision of composix e/x mesh (device 1 and 2) and implant of biological patch.Per op notes, ¿dense adhesions and the border of the mesh were identified in the left side of the abdomen.The abscess cavity between the fascia and the mesh was noted.A large amount of feculent and foul-smelling fluid as well as blood was obtained and the area was irrigated out.A large mesh was identified on the right side of the abdomen.There was a large abscess cavity.A small bowel and omental adhesions to the mesh were lysed.The mesh was completely removed from the loop of bowel.A small fistulous opening was noted and repaired with sutures.Noted weakness to the fascia with fascial defects near the umbilicus and right lower quadrant.A biological patch was placed and secured with sutures.¿ (b)(6) 2011 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic converted to open repair with implant of synthetic mesh.Per op notes, ¿a small defect within the fascia was identified.The small bowel, omentum and colon was adherent into the larger hernia defect and freed off.A synthetic mesh was placed in the fascial defects and secured with sutures.¿.

• 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: 24207872
• Report Number: 1213643-2026-00051
• Device Sequence Number: 9672320
• Product Code: FTL
• UDI-Device Identifier: 00801741031182
• UDI-Public: (01)00801741031182(10)43LND291
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 0123460
• Device Lot Number: 43LND291
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• 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: 54 YR
• Patient Sex: Female