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

Catalog Number	0112750
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Granuloma (1876); Scar Tissue (2060); Hernia (2240)
Date of Event	03/08/2004
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.This emdr represents the bard/davol perfix plug(device #2); additional supplemental emdr was submitted to represent the bard/davol kugel patch(device #3) and additional supplemental emdr was submitted to represent the bard/davol 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) 2001 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two perfix plug (right - device #1 & left - device #2).Per operative notes, ¿an indirect sac identified on the right groin was reduced and a perfix plug (device #1) was placed and sutured.A small indirect sac identified on the left side was returned into the peritoneal cavity and a perfix plug (device #2) was placed and sutured." (b)(6) 2004 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent open repair with the implant of kugel patch (left - device #3 & right - device #4).Per operative notes, ¿the scarring was noted.A direct hernia was identified on the left and a kugel patch (device #3) was placed ad sutured.On the right side, scarring was noted, hernia sac was completely reduced, and a kugel patch (device #4) was placed and sutured." (b)(6) 2012 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿dense adhesions were noted to the previously placed kugel patch (device #3) in the left groin.Hernia sac was reduced, and adhesions were lysed.A synthetic mesh was placed along with previously placed mesh (device #3) and tacked circumferentially." (b)(6) 2017 - patient was diagnosed with eft groin mass thereby underwent excision of mesh granuloma, lysis of adhesions.Per operative notes, ¿a firm, fibrous, encapsulated mass adherent of the spermatic cord was encountered and dissected.The mass was removed.There did appear to be pieces of mesh material consistent with large mesh granuloma.".

• 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 ; 4018258495
• MDR Report Key: 21958291
• Report Number: 1213643-2025-090194
• Device Sequence Number: 9274179
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(10)43HKD309
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Catalogue Number: 0112750
• Device Lot Number: 43HKD309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 18 YR
• Patient Sex: Male