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); Hernia (2240)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient¿s attorney and review of patient medical records: (b)(6)2015 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1) on (b)(6)2015.Per operative notes, ¿the hernia sac was dissected free of the surrounding structures and reduced.A perfix plug (device #1) was placed and secured with sutures.The floor was reinforced using the onlay patch.¿ (b)(6)2017 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per operative notes, ¿the hernia sac was dissected free of the surrounding structures and reduced.A perfix plug (device #2) was placed and secured with sutures.The floor was reinforced using the onlay patch.¿ (b)(6)2018 - patient was diagnosed with right inguinal hernia, neuralgia thereby underwent open repair with the implant of perfix plug (device #3), lysis of adhesion and explant of perfix plug (device #1).Per operative notes, ¿old mesh (device #1) was encountered, significant contraction of the mesh was noted.Deeper scar tissue appeared ilioinguinal nerve and this was divided laterally.The patch and the plug (device #1) adjacent to the cord was removed.A sheet of mesh (device #3) had placed over the floor around the cord and sutured.¿ (b)(6)2018 - patient was diagnosed with right inguinal hernia thereby underwent robotic assisted laparoscopic repair with the implant of 3dmax light mesh (device #4).Per operative notes, ¿laparoscopic lysis of adhesion was performed.The direct hernia was noted, preperitoneal space was completely freed.A 3dmax light mesh (device #4) was placed at copper¿s ligament and sutured.¿ attorney alleges that the patient had mesh migration, mesh shrinkage, nerve damage, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 8 months post implant of perfix plug, patient was diagnosed with hernia recurrence, adhesions thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence, adhesions as possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-feb-2017) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device #3).An 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.

• 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: 21603708
• Report Number: 1213643-2025-090131
• Device Sequence Number: 18445480
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)220128(10)HUBP1856
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: 01/28/2022
• Device Catalogue Number: 0112750
• Device Lot Number: HUBP1856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: 56 YR
• Patient Sex: Male