MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH

Catalog Number	0112770
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Deformation (2976)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240)
Date of Event	12/09/2010
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.Note, the manufacturing date (15-may-2009) is considered to be a best estimate.This emdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard/davol composix kugel mesh (device 1) and composix kugel mesh (device 3).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: on (b)(6) 2009 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of composix kugel mesh (device 1).Per op notes, ¿patient had developed a larger hernia from cholecystectomy trocar site.The hernia sac was found, and a composix kugel mesh (device 1) was placed inside the abdominal cavity and anchored to the fascial ring using sutures.¿ on (b)(6) 2009 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of perfix plug (device 2).Per op notes, ¿a large hernia palpable in right paramedian area.The piece omentum was dissected free.A perfix plug and mesh (device 2) was anchored to fascial ring and sutured.¿ (b)(6) 2010 - patient was diagnosed multiple recurrent incisional hernia thereby underwent open repair with the removal of composix kugel mesh (device 1) and perfix plug (device 2).Per op notes, ¿the large hernia in the upper midline was identified and also had another right sided defect right of the umbilicus slightly lower where perfix plug (device 1) was placed.Both the meshes (device 1, 2) were curled up with chronic inflammation and was protruding into the peritoneal cavity.The composix kugel mesh (device 1) and perfix plug (device 2) were completely removed.The flaps were done on both sides.A synthetic mesh was placed inside the abdominal cavity and anchored to overlying fascia using sutures.¿ on (b)(6) 2011 ¿ patient was diagnosed large recurrent incisional hernia thereby underwent open repair with the implant of composix kugel mesh (device 3).Per op notes, ¿the previously used synthetic mesh was then incised in the midline to enter the abdominal cavity and noted a large amount of loops of small bowel lodged in a pocket in left anterior abdominal wall.The synthetic mesh might have broken creating a window allowing herniation.Small adhesions were taken down.A composix kugel mesh (device 3) was laid flat with the small surface in the peritoneal cavity and anchored to fascial ring using sutures.¿ on (b)(6) 2011 ¿ patient was diagnosed with small bowel obstruction, mesh tear, recurrent incisional hernia thereby underwent open repair with the removal of mesh (device 3).Per op notes, ¿there was dense scar tissue in the subcutaneous space.The composix kugel mesh (device 3) had torn in the left lateral side which attached to fascia.There was a large amount of small bowel inside the left hernia sac.The entire composix kugel mesh (device 3) was removed along with sutures.The synthetic mesh was left in place.Dense adhesions at level of small bowel were noted.There was a laceration of distal terminal ileum.The two small defects in mid and proximal ileum were repaired using sutures and small bowel resection was done.The biological mesh was then placed on top of the fascia.The previously placed fascial sutures and the lateral margins were then placed through the mesh using sutures.¿.

• Brand Name: PERFIX PLUG
• 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: 23788640
• Report Number: 1213643-2025-01200
• Device Sequence Number: 18759433
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)150328(10)HUTC0423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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 Expiration Date: 03/28/2015
• Device Catalogue Number: 0112770
• Device Lot Number: HUTC0423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2009
• 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: 75 YR
• Patient Sex: Female