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

Catalog Number	0112770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medical record and plaintiff profile form: (b)(6) 2015 - patient was diagnosed with left direct and indirect inguinal hernia thereby underwent open repair with implant of perfix plug (device 1 and device 2).Per operative notes, ¿a left groin incision was made.Both direct and indirect hernia sacs were dissected out.Two large perfix plug (device 1 and device 2) were placed into the direct and indirect inguinal floor and secure it with sutures.¿ (b)(6) 2015 ¿ patient was diagnosed with right direct and indirect inguinal hernia thereby underwent open repair with implant of perfix plug (device 3 and device 4).Per operative notes, ¿a right groin incision was made into right inguinal floor.Both direct and indirect hernia sacs were dissected out.Two perfix plug (device 3 and device 4) were placed into the right inguinal floor and secure it with sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with left inguinal pain; recurrent left inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 5).Per operative notes, ¿a supraumbilical incision was made.Left inguinal hernia sac was dissected out.Previously placed meshes (device 1 and device 2) were intact.A large 3dmax mesh (device 5) was placed into the left inguinal floor and secure it with sutures.¿ (b)(6) 2017 - patient was diagnosed with left groin pain, adhesion thereby underwent laparoscopic repair with lysis of adhesion.Per operative notes, ¿a small incision was made into the peritoneal cavity.There were no adhesions or any obvious hernia noted on the right side.On the left side dense number of adhesions were present.Lysis of adhesions were done.All adhesions were taken down.The defect was closed with seprafilm.¿.
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-2015) is considered to be a best estimate.This mdr represents the perfix plug (device 2).Three additional supplemental emdr were submitted to represent the perfix plug (device 1), perfix plug (device 3) and 3dmax mesh (device 5).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 ; 8005566756
• MDR Report Key: 24003009
• Report Number: 1213643-2026-00008
• Device Sequence Number: 16079492
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)200528(10)HUZE1457
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: 05/28/2020
• Device Catalogue Number: 0112770
• Device Lot Number: HUZE1457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2015
• 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; Disability
• Patient Age: 28 YR
• Patient Sex: Male