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

Catalog Number	0112980
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/30/2019
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-2018) is considered to be a best estimate.This emdr 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) 2019 - patient was diagnosed for bilateral recurrent inguinal hernias thereby underwent open repair with implant of two perfix plug (left - device #1 & right - device #2).Per op notes, "for left inguinal defect, a perfix plug (left - device #1) was placed and sutured.For right inguinal hernia defect, a perfix plug (right - device #2) was placed and sutured." (b)(6) 2019 - patient was diagnosed for bilateral recurrent inguinal hernias, mesh migration thereby underwent robotic assisted laparoscopic repair with explant of perfix plug (right - device #2) and implant of 3dmax mesh (right - device #3 & left - device #4).Per op notes, "in right side, the adhered mesh (device #2) migrated was dissected and removed entirely.A 3dmax mesh (right - device #3) was placed and tacked.In left side, the defect was reduced and a 3dmax mesh (left - device #3) was placed 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: 22685397
• Report Number: 1213643-2025-00710
• Device Sequence Number: 8936928
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)230528(10)HUCS0039
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 05/28/2023
• Device Catalogue Number: 0112980
• Device Lot Number: HUCS0039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2018
• 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: 52 YR
• Patient Sex: Male