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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	01/09/2020
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-jun-2014) is considered to be a best estimate.This mdr represents the perfix plug (device 8).Additional supplemental emdr's were submitted to represent the ventrio mesh (device 1), bard flat mesh (device 4), bard flat mesh (device 6), ventralex st mesh (device 7).Additional mdr's were submitted to represent the bard soft mesh (device 2) and perfix plug (device 5).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) 2012- patient was diagnosed with incisional hernia, thereby underwent open repair with implant of ventrio mesh (device 1), bard soft mesh (device 2).Per op notes, ¿the hernia defect in the abdominal region was dissected.A ventrio mesh (device 1) was placed preperitoneal and sutured.A bard soft mesh (device 2) was placed as an onlay to the fascia and sutured¿.(b)(6) 2012 - patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with explant of ventrio mesh (device 1), bard soft mesh (device 2) and implant of allomax surgical graft (device 3), bard flat mesh (device 4).Per op notes, ¿the previously made scar was removed.The sac in the abdominal region along with the previously placed mesh was removed.An allomax surgical graft (device 3) was placed intra abdominally and sutured.A bard flat mesh (device 4) was placed as an onlay and sutured¿.(b)(6) 2013- patient was diagnosed with incisional hernia, thereby underwent open repair with implant of perfix plug (device 5) and bard flat mesh (device 6).Per op notes, ¿in midline incision, an opening in the fascia was identified and a perfix plug (device 5) was placed and sutured.Above this a bard flat mesh (device 6) was placed and sutured¿.(b)(6) 2014- patient was diagnosed with incisional hernia, thereby underwent open repair with implant of ventralex st mesh (device 7).Per op notes, ¿the hernia defect was identified in the periumbilical region and was dissected.A ventralex st mesh (device 7) was placed intra-abdominally and sutured¿.(b)(6) 2014- patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of perfix plug (device 8).Per op notes, ¿the hernia sac was freed circumfascially and reduced intra-abdominally.An extra large perfix plug (device 8) was placed and sutured¿.(b)(6) 2017- patient was diagnosed with recurrent incisional hernia, thereby underwent open repair.Per op notes, ¿the hernia sac was removed from the right lower quadrant and sutured¿.(b)(6) 2020- patient was diagnosed with recurrent incisional hernia and pain, thereby underwent robotic assisted laparoscopic repair with explant of the meshes that were placed in lower midline (device 4, 5 6,7, 8), implant of 2 bard soft meshes (device 9 and 10).Per op notes, ¿adhesions were noted in the abdominal region where the loops of small bowel found adherent to the 3 old pieces of mesh and the adhesions were lysed.Once adhesiolysis completed, multiple hernia defects were identified.Meshes placed in lower midline (device 4, 5 6,7, 8) were excised.Two bard soft meshes (device 9 and 10) were placed in retrorectus space and was sutured¿.

• 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: 24374673
• Report Number: 1213643-2026-00153
• Device Sequence Number: 5572142
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)190628(10)HUYF0195
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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 Expiration Date: 06/28/2019
• Device Catalogue Number: 0112780
• Device Lot Number: HUYF0195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2014
• 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: 64 YR
• Patient Sex: Male