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

Catalog Number	0112970
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	02/20/2018
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-2013) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (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 bilateral inguinal hernias thereby underwent open repair with the implant of bard flat mesh (device #1) for right inguinal hernia and perfix plug (device #2) for left inguinal hernia.Per operative notes, "on left side, an indirect hernia was dissected from cord structures.An perfix plug onlay patch (device #2) was placed and sutured.On right side, a large indirect hernia sac was noted and excised.Perfix plug (device #2) was placed into the defect, and a bard flat mesh (device #1) and was placed over the floor and sutured." (b)(6) 2016 - patient recurrent right inguinal hernia got postponed due to the risk of sudden cardiac death associated with brugada syndrome.(b)(6) 2018 - patient was diagnosed with recurrent bilateral inguinal hernias and groin pain and umbilical hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #3, #4).Per operative notes, "on left side, a direct inguinal hernia was noted.There is no evidence of prior mesh.A 3dmax mesh (device #4) was placed and tacked.On right side, a large direct hernia was noted with previous mesh plug in internal ring adherent to vas deferens.A 3dmax mesh (device #5) was placed and tacked.The umbilical hernia was repair primarily using sutures.".

• 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: 22160571
• Report Number: 1213643-2025-00437
• Device Sequence Number: 20688400
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(17)180428(10)HUXC1508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 04/28/2018
• Device Catalogue Number: 0112970
• Device Lot Number: HUXC1508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 80 KG