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

Catalog Number	0112970
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	12/12/2017
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-feb-2011) is considered to be a best estimate.This emdr represents the perfix plug (device #2).An additional supplemental emdrs were submitted to represent the perfix plug (device #1) & 3d max (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: (b)(6) 2011 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device #1 & #2).Per operative notes, ¿the large hernia sac was identified in right inguinal region and dissected.A perfix plug (device #1) was placed and sutured.The same procedure was performed at left inguinal region and implanted with perfix plug (device #2).¿ (b)(6) 2017 - patient was diagnosed with recurrent bilateral inguinal hernia with pain thereby underwent laparoscopic repair with partial excision of mesh (device #1) and complete excision of mesh (device #2) with implant of 3d max (device #3 & #4).Per operative notes, ¿the plug in right side expanding to the direct space was partially removed, remaining portion adherent to fascia was left in place.The hernia defect was repaired with a large 3d max (device #3) and tacked.The plug on left side migrated to pubic bone was removed entirely.A direct hernia was repaired with a 3d max (device #4) and tacked.¿.
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-feb-2011) is considered to be a best estimate.H11: this supplemental emdr is submitted to correct imdrf annex a code and initial reporter facility name.Corrected fields: h6 (imdrf annex a code), e1 (initial reporter facility name).This supplemental emdr represents the perfix plug (device #2).Additional supplemental emdrs were submitted to represent the perfix plug (device #1) & 3dmax (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: (b)(6) 2011: patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device #1 & #2).Per operative notes, ¿the large hernia sac was identified in right inguinal region and dissected.A perfix plug (device #1) was placed and sutured.The same procedure was performed at left inguinal region and implanted with perfix plug (device #2).¿ (b)(6) 2017: patient was diagnosed with recurrent bilateral inguinal hernia with pain thereby underwent laparoscopic repair with partial excision of mesh (device #1) and complete excision of mesh (device #2) with implant of 3d max (device #3 & #4).Per operative notes, ¿the plug in right side expanding to the direct space was partially removed, remaining portion adherent to fascia was left in place.The hernia defect was repaired with a large 3d max (device #3) and tacked.The plug on left side migrated to pubic bone was removed entirely.A direct hernia was repaired with a 3d max (device #4) and tacked.¿.

• 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: 22139604
• Report Number: 1213643-2025-00428
• Device Sequence Number: 12518338
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)160228(10)HUVB1155
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 02/28/2016
• Device Catalogue Number: 0112970
• Device Lot Number: HUVB1155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2011
• 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: 53 YR
• Patient Sex: Male