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

Catalog Number	0112750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/21/2007
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 emdr was submitted to represent the bard/davol perfix plug (device #1).Additional supplemental emdr's were submitted to represent the two bard/davol mesh ¿ ventralex (device #2 & #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: (b)(6) 2005 ¿ patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with the implant of perfix plug (device #1).Per op notes, ¿the hernia sac was separated from overlying umbilicus.A small perfix plug (device #1) was placed just deep to fascia using sutures.¿ (b)(6) 2007 - patient was diagnosed with incisional ventral hernia thereby underwent open repair with the removal of mesh (device #1) and implant of ventralex mesh (device #2).Per op notes, ¿the previous hernia and new hernia made into single defect.A perfix plug (device #1) was excised and a ventralex mesh (device #2) was placed deep to abdominal wall and positioned using sutures.¿ (b)(6) 2008 ¿ patient was diagnosed with chronic abdominal pain , adhesion, delaminated mesh thereby underwent laparoscopic to open repair with removal of mesh (device #2) and implant of ventralex mesh (device #3).Per op notes, ¿adhesions had been taken down and the mesh (device #2) was profoundly contracted and delaminated from the abdominal wall surface was excised.A large ventralex mesh (device #3) was secured to peritoneal surface using tacks.¿ (b)(6) 2008 ¿ patient was diagnosed with small bowel obstruction secondary to intraabdominal adhesions thereby underwent laparoscopic repair.Per op notes, ¿adhesions were taken down.The small bowel was eviscerated through the incision and fluid was milked to area concerning for bowel perforation.¿ (b)(6) 2017 ¿ patient had abdominal pain and diagnosed with left spigelian hernia and mesh eroded to small intestine thereby underwent laparoscopic repair with the removal of infected mesh (device #3).Per op notes, ¿scar tissue was excised and adhesion was lysed.Small spigelian hernia was found on left side.Mesh (device #3) had eroded into the small bowel was resected enbloc.¿.

• 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: 22556295
• Report Number: 1213643-2025-00658
• Device Sequence Number: 9681684
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 0112750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/21/2025
• 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: 29 YR
• Patient Sex: Female