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

Catalog Number	0112970
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060)
Date of Event	04/22/2020
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-mar-2012) is considered to be a best estimate.This mdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the perfix plug (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) 2013 ¿ patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of two perfix plugs (device 1 and 2).Per operative notes, ¿a large direct inguinal hernia with indirect component was noted.A large defect was dissected free, placed back into the abdominal cavity.An extra-large perfix plug (device 1) was placed and sutured in place to conjoined tendon.The internal ring was slightly loosened and another large perfix plug (device 2) was placed and sutured in place to the internal ring along with prior mesh (device 1) itself.The fascia was closed and sutured circumferentially.¿ (b)(6) 2020 - patient was diagnosed with right lower quadrant pain and meshoma thereby underwent robotic assisted laparoscopic repair with removal of meshes (device 1 and 2) and implant of 3dmax mesh (device 3).Per operative notes, ¿the mesh plugs (device 1 and 2) with signs of chronic inflammation were noted.The extensive scar tissue and small bowel and colon were dissected away from the mesh plugs (device 1 and 2).The meshes (device 1 and 2) were removed carefully and fascia was closed with sutures.To the fascial defect a right sided, 3dmax mesh (device 3) was placed over the defect covering direct, indirect and femoral spaces and sutured circumferentially.¿.

• 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: 24256466
• Report Number: 1213643-2026-00078
• Device Sequence Number: 18231601
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)170328(10)HUWC1709
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 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 Expiration Date: 03/28/2017
• Device Catalogue Number: 0112970
• Device Lot Number: HUWC1709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2012
• 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: 57 YR
• Patient Sex: Male